Cancer Treatment

Abstract

Methods for treating cancer with erdafitinib are provided. [Solution] A method for treating cancer, comprising administering to a subject in need thereof, particularly a cancer patient, an amount of erdafitinib such that the serum phosphate concentration is in the range of 5.5 mg / dL to less than 7 mg / dL, inclusive, or in the range of 5.5 mg / dL to 9 mg / dL, inclusive.

Description

Technical Field

[0001] The present invention provides a treatment for cancer with erdafitinib that limits potential toxicities, such as nail toxicity, while having a high potential for response.

[0002] The present invention provides a treatment for cancer with erdafitinib that limits potential toxicities while maximizing erdafitinib exposure.

[0003] The present invention provides a treatment for cancer with erdafitinib having a high objective response rate, specifically at least 40% objective response rate, specifically at least 40% objective response rate in cancer patients who have not received chemotherapy, at least 40% objective response rate in cancer patients who have disease progression after one previous line of chemotherapy, and at least 40% objective response rate in cancer patients who have disease progression after two or more previous lines of chemotherapy.

[0004] The present invention provides a treatment for cancer with erdafitinib having a short time to response, specifically a median time to response of less than 2 months.

Brief Description of the Drawings

[0005] [Figure 1] Figure 1 represents the study scheme of a Phase 2 multi-site, open-label trial to evaluate the efficacy and safety of erdafitinib in subjects with metastatic or surgically unresectable urothelial carcinoma having a selected FGFR (fibroblast growth factor receptor) gene change (FGFR translocation or mutation). [Figure 2] Figure 2 represents a waterfall plot of the percentage maximum decrease from baseline in the sum of target lesion diameters among patients treated with an 8 mg continuous regimen of erdafitinib (Regimen 3 of the Phase 2 trial (Figure 1)). M, FGFR mutation; T, FGFR translocation.​​​​​​ [Modes for carrying out the invention]

[0006] The present invention limits potential toxicity while already having the first cycle of treatment (e.g., specific (This includes the first 28 days of treatment with continuous daily medication or the first 21 days of treatment.) And further treatment cycles (for example, specifically 28 days with continuous daily medication) Maximize erdafitinib exposure during the cycle (set to / cycle or 21 days / cycle) We offer cancer treatment with dafitinib.

[0007] This invention maximizes erdafitinib exposure and provides subjects who require erdafitinib. Specifically, within the target serum phosphate range, including 5.5 mg / dL, from 5.5 mg / dL to 7 mg / dL. A range of less than mg / dL, or including 5.5 mg / dL and ranging from 5.5 mg / dL to 9 mg / dL The following range is rapidly reached to suppress phosphate toxicity in cancer treated with erdafitinib. Provide treatment.

[0008] Erdafitinib or N-(3,5-dimethoxyphenyl)-N'-(1-methyleth (Lu)-N-[3-(1-methyl-1H-pyrazole-4-yl)quinoxaline-6-yl] Ethane-1,2-diamine is a receptor for fibroblast growth factor (FGFR) 1, 2, 3, 4 It is a tyrosine kinase inhibitor.

[0009] The chemical structure of erdafitinib is [ka] That is the case.

[0010] Serum phosphate concentration may represent an on-target pharmacodynamic marker indicating FGFR target engagement by erdafitinib. The concentration of serum phosphate is likely to increase with target engagement. However, it is necessary to monitor serum phosphate concentration to minimize, avoid, or control acute and long-term hyperphosphatemia. When the serum phosphate concentration is 5.5 mg / dL or higher, a higher proportion of patients were found to respond to erdafitinib treatment. In one embodiment, the proportion of patients showing an objective response rate is at least 15%, or 20%, or 25%, or 30%, or 35%, or 40%, or 45%, 50%, 55%, 60%, 65%, or over 65%, depending on the type of cancer.

[0011] In one embodiment, exposure to erdafitinib results in an objective response rate of at least 15%, or 20%, or 25%, or 30%, or 35%, or 40%, or 4 5%, 50%, 55%, 60%, 65%, or over 65%, depending on the type of cancer.

[0012] In one embodiment, the serum phosphate concentration of cancer patients is 5 .5 mg / dL or higher, specifically including 5.5 mg / dL and ranging from 5.5 mg / dL to less than 7 mg / dL or including 5.5 mg / dL and ranging from 5.5 mg / dL to 9 mg / dL or less, and provides an objective response rate of at least 15%, or 20%, or 25%, or 30%

[0013] , or 35%, or 40%, or 45%, 50%, 55%, 60%, 65%, or over 65%, depending on the type of cancer. In one embodiment, exposure to erdafitinib results in an objective response rate of at least 15%, or 20%, or 25%, or 30%, or 35%, or 40%, or 4 5%, 50%, 55%, 60%, 65%, or over 65%, depending on the type of cancer. In one embodiment, the serum phosphate concentration of cancer patients is 5

[0014] .5 mg / dL or higher, specifically including 5.5 mg / dL and ranging from 5.5 mg / dL to less than 7 mg / .5 mg / dL or higher, specifically including 5. mg / dL and ranging from 5.5 mg / dL to less than 7 mg / dL or including 5.5 mg / dL and ranging from 5.5 mg / dL to 9 mg / dL or less, and provides an objective response rate of at least 15%, or 20%, or 25%, or 30% , or 35%, or 40%, or 45%, 50%, 55%, 60%, 65%, or over 65%, depending on the type of cancer. In one embodiment, the serum phosphate concentration of cancer patients is 5 .5 mg / dL or higher, specifically including 5.5 mg / dL and ranging from 5.5 mg / dL to less than 7 mg /

[0015] In one embodiment, the method for treating cancer described herein or the use for manufacturing a medicament for treating cancer described herein or the erdafitinib for use in treating cancer described herein provides an objective response rate of at least 15%, or 20%, or 25%, or 30% or 35%, or 40%, or 45%, 50%, 55%, 60%, 65%, or 65% or more.

[0016] In one embodiment, the cancer is urothelial cancer, metastatic or surgically unresectable urothelial cancer, specifically urothelial cancer having a selected FGFR gene alteration, metastatic or surgically unresectable urothelial cancer, the method for treating cancer described herein or the use for manufacturing a medicament for treating cancer described herein or the erdafitinib for use in treating cancer described herein provides an objective response rate of at least 40%, specifically about 40 %, about 41%, about 42%, about 43%, about 44%, about 45 %, about 46%, about 47%, about 48%, about 49%, about 50 %. Specifically, the objective response rate is in the range of 40% to 50%, or in the range of 40% to 45%, or in the range of 42% to 45%.

[0017] In one embodiment, in patients having urothelial cancer, metastatic or surgically unresectable urothelial cancer, specifically urothelial cancer having a selected FGFR gene alteration, metastatic or surgically unresectable urothelial cancer, the objective response rate upon exposure to erdafitinib according to the dosing regimen disclosed herein is at least 40%, specifically about 40%, about 41%, about 42%, about ...... ......, about 49%, about 50%.

[0018] 41%, approximately 42%, approximately 43%, approximately 44%, approximately 45%, approximately It is 46%, approximately 47%, approximately 48%, approximately 49%, and approximately 50%. Physically, the objective response rate is in the range of 40% to 50%, or 40% to 45%, or 4 The range is 2% to 45%.

[0018] In one embodiment, the method of treating cancer described herein or the method described herein Use for the manufacture of pharmaceuticals for the treatment of cancer or use for the treatment of cancer as described herein Erdafitinib for this purpose should be administered for at least 4 months, or at least 5 months, or less It also provides a median duration of response of 6 months, or at least 7 months.

[0019] In one embodiment, the cancer is urothelial carcinoma, metastatic or surgically unresectable urothelial carcinoma, Physically, it is urothelial carcinoma with selected FGFR gene mutations, metastatic or unresectable. Urothelial carcinoma, the method of treatment for cancer described herein or cancer described herein For use in the manufacture of pharmaceuticals for the treatment of cancer as described herein Erdafitinib for this purpose is prescribed for at least 4 months, or at least 5 months, or at least It gives a median response duration of 6 months, or at least 7 months, or approximately 4 months, or approximately 5 months. It is one month, or approximately six months, or approximately seven months. Specifically, the median duration of response is 4 to 7 months. It is within the range of [the specified range].

[0020] In one embodiment, urothelial carcinoma, metastatic or unresectable urothelial carcinoma, specifically This refers to urothelial carcinoma, metastatic or unresectable urinary tract cancer with selected FGFR gene mutations. In patients with epithelial carcinoma, erdafitinib according to the drug regimen disclosed herein. The median duration of response upon exposure to is at least 4 months, or at least 5 months, or less Both are 6 months, or at least 7 months, or about 4 months, or about 5 months, or about It is 6 months, or approximately 7 months. Specifically, the median duration of response is in the range of 4 to 7 months. ru.

[0021] In one embodiment, the method of treating cancer described herein or the method described herein Use for the manufacture of pharmaceuticals for the treatment of cancer or use for the treatment of cancer as described herein Erdafitinib for this purpose should be administered for at least 4 months, or at least 5 months, or less This also provides a median progression-free survival of 6 months, or at least 7 months.

[0022] In one embodiment, the cancer is urothelial carcinoma, metastatic or surgically unresectable urothelial carcinoma, Physically, it is urothelial carcinoma with selected FGFR gene mutations, metastatic or unresectable. Urothelial carcinoma, the method of treatment for cancer described herein or cancer described herein For use in the manufacture of pharmaceuticals for the treatment of cancer as described herein Erdafitinib for this purpose is prescribed for at least 4 months, or at least 5 months, or at least To give a median progression-free survival of 6 months, or at least 7 months, or approximately 4 months, Or approximately 5 months, or approximately 6 months, or approximately 7 months. Specifically, median progression-free survival. This ranges from 4 to 7 months.

[0023] In one embodiment, urothelial carcinoma, metastatic or unresectable urothelial carcinoma, specifically This refers to urothelial carcinoma, metastatic or unresectable urinary tract cancer with selected FGFR gene mutations. In patients with epithelial carcinoma, erdafitinib according to the drug regimen disclosed herein. The median progression-free survival at the time of exposure to is at least 4 months, or at least 5 months, or At least 6 months, or at least 7 months, or about 4 months, or about 5 months. Or approximately 6 months, or approximately 7 months. Specifically, the median progression-free survival is 4 to 7 months. This is the range of the moon.

[0024] The method of treating cancer described herein or the pharmaceutical product for treating cancer described herein For use in the manufacture of products or for use in the treatment of cancer as described herein, Eldafiti Median time to response to the nib e) is very short. In one embodiment, the median time to reaction is less than 2 months, specifically Generally, it's less than 1.5 months, specifically around 1.4 months.

[0025] In one embodiment, the cancer is urothelial carcinoma, metastatic or surgically unresectable urothelial carcinoma, Physically, it is urothelial carcinoma with selected FGFR gene mutations, metastatic or unresectable. Urothelial carcinoma, the method of treatment for cancer described herein or cancer described herein For use in the manufacture of pharmaceuticals for the treatment of cancer as described herein Erdafitinib for this purpose has a time to response of less than 2 months, specifically less than 1.5 months. The median is given, which is approximately 1.4 months.

[0026] In one embodiment, urothelial carcinoma, metastatic or unresectable urothelial carcinoma, specifically This refers to urothelial carcinoma, metastatic or unresectable urinary tract cancer with selected FGFR gene mutations. In patients with epithelial carcinoma, erdafitinib according to the drug regimen disclosed herein. The median time to response after exposure to was less than 2 months, specifically less than 1.5 months. Specifically, it is around 1.4 months.

[0027] Surprisingly, the cancer treatments described herein, specifically urothelial carcinoma, metastatic or surgical cancers Unresectable urothelial carcinoma, specifically urothelial carcinoma with selected FGFR gene mutations, The response to treatment of metastatic or surgically unresectable urothelial carcinoma is, for example, in patients who have not received chemotherapy. Patients receiving treatment, specifically patients who are unsuitable for cisplatin and have not received previous chemotherapy, or patients with a previous one line of chemotherapy Patients who experience disease progression after therapy, or disease progression after two or more previous lines of chemotherapy. It was found to be unrelated to the number of previous treatment lines received by patients with this condition. (One embodiment) In this context, the response to treatment differs among patients with different numbers of previous treatments, for example, Patients who have not received chemotherapy, specifically patients who have not received chemotherapy for whom cisplatin is unsuitable, and patients who have previously received 1L Patients who have experienced disease progression after chemotherapy, or after two or more previous lines of chemotherapy. The results are similar in patients with disease progression. In one embodiment, the previous line of chemotherapy was used Patients who have, for example, disease progression after a previous line of chemotherapy or previous The response to cancer treatment in patients who have experienced disease progression after two or more lines of chemotherapy is: It's not worse than in patients who haven't received chemotherapy.

[0028] A serum phosphate concentration of 7 mg / dL or higher, specifically more than 9 mg / dL, indicates a temporary ergonomic state. This may be a reason for discontinuing fitinib treatment or adjusting (reducing) the erdafitinib dosage. And was discovered.

[0029] In one embodiment, temporary erdafitinib discontinuation results in serum phosphate levels returning to 5. This indicates the discontinuation of erdafitinib administration until the dose falls below 5 mg / dL.

[0030] In one embodiment, a temporary erdafitinib discontinuation is performed when the serum phosphate concentration returns to 7m This indicates the discontinuation of erdafitinib administration until the level falls below g / dL.

[0031] An effective and safe treatment with erdafitinib is when the serum phosphate concentration is 5.5 mg / dL included in the range of 5.5 mg / dL to less than 7 mg / dL or 5.5 mg / dL included in the range of 5 Eldaf is administered at therapeutically effective doses in the range of 0.5 mg / dL to 9 mg / dL or less. It was found that administering itinib was the solution.

[0032] Serum phosphate concentration is, for example, ab65622 Phosphate Assay Ki It can be measured using commercially available kits such as t(Colorimetric)(Abcam).

[0033] Daily, preferably once a day, continuous (daily unless the context indicates otherwise, during treatment) (Without interruption or intermittent administration) Administration of 8 mg of erdafitinib may lead to potential drug-related complications. While minimizing the need to interrupt treatment or reduce dosage due to adverse events, Eldafi Subjects requiring tinib administration, specifically cancer patients, with a serum phosphate concentration of 5.5 mg / dL. It was found that the likelihood of reaching or exceeding a certain degree increased.

[0034] 5. Treatment involves a continuous administration of 8 mg of erdafitinib daily, preferably once daily. A serum phosphate concentration of 5 mg / dL is reached during the first cycle of erdafitinib treatment (for example, the first It has been found that this can be reached during the 28th day or the first 21 days. Daily, preferably Erdafitinib administration involves a continuous dose of 8 mg of erdafitinib once daily. The subjects who need it, specifically cancer patients, will be able to complete the first cycle of erdafitinib treatment. The serum phosphate concentration should be reduced to 5.5 mg / dL as early as possible (for example, on day 14 ± 2 of treatment). The likelihood of reaching or exceeding a certain threshold increases, potentially leading to treatment interruption or other adverse drug events. This approach minimizes the need for dose reduction while maximizing effective treatment. It was released.

[0035] In one embodiment, subjects requiring erdafitinib treatment, specifically cancer patients Serum phosphate levels will be monitored.

[0036] In one embodiment, subjects requiring erdafitinib treatment, specifically cancer patients Subjects whose serum phosphate levels are monitored and who require erdafitinib treatment, specifically cancer patients. Early onset of symptoms associated with erdafitinib, or FGFR inhibitors in general or specifically, as reported by patients. Early onset toxicity is monitored.

[0037] In one embodiment, early FGFR inhibitors in general or specifically related to erdafitinib The toxic effects during this period include grade 3 or higher xerostomia or stomatitis / mucositis, dry skin, and dry mouth. (i) Nail toxicity (or Grade 2 if it lasts longer than 1 week) or Grade 2 or higher ocular toxicity (cornea) Femoritis, central serious retinopathy (Including retinal pigment epithelial detachment). Early-onset toxicity may be a reason for discontinuing treatment or reducing the dosage. It depends on the doctor's judgment and the patient's condition.

[0038] In one embodiment, early onset toxicity or FGFR inhibitors in general as described herein or Early-onset toxicity specifically associated with erdafitinib is usually grade 3 or higher. Possible causes include: stomatitis / mucositis, dry skin, dry eyes, nail toxicity, or specific eye conditions. Toxicity (keratitis, or retinopathy also known as central serous retinopathy, retinal detachment, retinal edema, retina) One or more of the following (pigment epithelial exfoliation, chorioretinitis), or FGFR inhibitors in general or specific. FGFR inhibition is associated with other significant toxicity thought to be uniquely linked to erdafitinib. Clinically significant toxicity thought to be related to erdafitinib in general or specifically. This means that early-onset toxicity may be a reason to discontinue treatment or reduce the dosage. It is up to the physician's discretion. It depends on the individual and the patient's condition.

[0039] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and less than 7 mg / dL The present invention relates to a method comprising administering an amount of erdafitinib such that it is within a range. In this case, the dose of erdafitinib is 8 mg, specifically 8 mg administered daily. The present invention relates to a method for treating cancer, which is available to subjects who require it, specifically cancer patients. In patients, serum phosphate levels should be within the first cycle of erdafitinib administration (treatment cycle) The period is set, for example, for the first 28 days of administration or the first 21 days of administration, serum phosphate The concentration is determined on the 28th day or around that date, or on the 21st day or around that date, or on the 14th day. (Evaluated at or before / after the eye) Contains 5.5 mg / dL, ranging from 5.5 mg / dL to 7 mg / dL The present invention relates to a method that involves administering an amount of erdafitinib such that it reaches a range of less than [amount missing]. In one embodiment, the amount of erdafitinib is 8 mg, specifically administered daily. It is 8 mg.

[0040] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and 9 mg / dL or less The present invention relates to a method comprising administering an amount of erdafitinib such that it is within a range. In this case, the dose of erdafitinib is 8 mg, specifically 8 mg administered daily. The present invention relates to a method for treating cancer, which is available to subjects who require it, specifically cancer patients. In patients, serum phosphate levels should be within the first cycle of erdafitinib administration (treatment cycle) The period is set, for example, for the first 28 days of administration or the first 21 days of administration, serum phosphate The concentration is determined on the 28th day or around that date, or on the 21st day or around that date, or on the 14th day. (Evaluated at or before / after the eye) Contains 5.5 mg / dL and ranges from 5.5 mg / dL to 9 mg / dL The method involves administering an amount of erdafitinib such that it reaches the following ranges. In one embodiment, the amount of erdafitinib is 8 mg, specifically administered daily. It is 8 mg.

[0041] This invention relates to serum phosphate concentrations ranging from 5.5 mg / dL to 7 mg. Eldaf for the manufacture of pharmaceuticals for the treatment of cancer in amounts such as less than / dL This invention relates to the use of erdafitinib. The present invention relates to the serum phosphate concentration when erdafitinib is administered. Within one cycle (the treatment cycle period is, for example, the first 28 days of administration or the first day of administration) The treatment period is set to 21 days, and serum phosphate concentration is measured on the 28th day of administration or around that time, or on the 21st day. (Evaluated around or after that date, or on the 14th day or around that date) Contains 5.5 mg / dL. For the treatment of cancer, a drug that reaches a dose in the range of 5 mg / dL to less than 7 mg / dL This relates to the use of erdafitinib for the manufacture of pharmaceuticals. In one embodiment, erdafitinib The dosage of tinib is 8 mg, specifically 8 mg administered daily.

[0042] This invention relates to serum phosphate concentrations ranging from 5.5 mg / dL to 9 mg. Eldaf for the manufacture of pharmaceuticals for the treatment of cancer in amounts such as below / dL This invention relates to the use of erdafitinib. The present invention relates to the serum phosphate concentration when erdafitinib is administered. Within one cycle (the treatment cycle period is, for example, the first 28 days of administration or the first day of administration) The treatment period is set to 21 days, and serum phosphate concentration is measured on the 28th day of administration or around that time, or on the 21st day. (Evaluated around or after that date, or on the 14th day or around that date) Contains 5.5 mg / dL. For the treatment of cancer, a dose that reaches a range of 5 mg / dL to 9 mg / dL or less. This relates to the use of erdafitinib for the manufacture of pharmaceuticals. In one embodiment, erdafitinib The dosage of tinib is 8 mg, specifically 8 mg administered daily.

[0043] This invention relates to serum phosphate concentrations ranging from 5.5 mg / dL to 7 mg. Erdafitinib is administered in doses below 1 / dL and is used for the treatment of cancer. The present invention relates to erdafitinib for the purpose of reducing serum phosphate concentration. Within the first cycle of administration (the treatment cycle period is, for example, the first 28 days of administration or administration) The serum phosphate concentration is set for the first 21 days, on the 28th day of administration or around that time, or (Evaluated on day 21 or around that date, or on day 14 or around that date) 5.5 mg / dL In amounts that reach a range of 5.5 mg / dL to less than 7 mg / dL, erdafitini The present invention relates to erdafitinib, administered for use in the treatment of cancer. In one embodiment, The dosage of erdafitinib is 8 mg, specifically 8 mg administered daily. ru.

[0044] This invention relates to serum phosphate concentrations ranging from 5.5 mg / dL to 9 mg. Erdafitinib is administered in doses below a certain level ( / dL) and is used for the treatment of cancer. The present invention relates to erdafitinib for the purpose of reducing serum phosphate concentration. Within the first cycle of administration (the treatment cycle period is, for example, the first 28 days of administration or administration) Set for the first 21 days, serum phosphate concentration on day 28 of administration or around that time, (Evaluated on day 21 or around that date, or on day 14 or around that date) 5.5 mg / dL In amounts that reach a range of 5.5 mg / dL to 9 mg / dL or less, erdafitini The present invention relates to erdafitinib, administered for use in the treatment of cancer. In one embodiment, The dosage of erdafitinib is 8 mg, specifically 8 mg administered daily. ru.

[0045] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. Regarding the method, dosage adjustments can be made based on serum phosphate concentration and are non-toxic. It can be observed in this regard.

[0046] The present invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer, The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically once a day. Erdafitinib for the manufacture of a drug for the treatment of cancer, for continuous administration. Regarding use: Dosage adjustments can be made based on serum phosphate concentration, and no toxicity is present. It can be observed in this regard.

[0047] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. This concerns erdafitinib for use in the treatment of cancer. Dosage adjustments are made to serum phosphorus This can be done based on the salt acid concentration, and observations can be made regarding the absence of toxicity.

[0048] During treatment with erdafitinib administered daily, preferably once daily, in a continuous dose of 8 mg. The serum phosphate concentration can be monitored. In addition, increase the dose of erdafitinib daily, preferably once daily, for a continuous period of 9 months. It can be gradually increased to g. In one embodiment, serum phosphate to determine whether to gradually increase. The concentration of erdafitinib is determined on the treatment day during the first cycle of erdafitinib treatment, specifically on the day of treatment. The measurement is taken 14 ± 2 days after tinib administration, more specifically on day 14.

[0049] During treatment with erdafitinib administered daily, preferably once daily, in a continuous dose of 8 mg. The serum phosphate concentration can be monitored. If the serum phosphate concentration is less than 7 mg / dL, or It contains 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, or 9 mg / If the level is below dL, increase the dose of erdafitinib daily, preferably 1 dL per day. The dose can be gradually increased to 9 mg in succession. In one embodiment, to determine whether to gradually increase the dose... The serum phosphate concentration is specifically measured on the treatment day during the first cycle of erdafitinib treatment. It is measured approximately 14 ± 2 days after erdafitinib administration, more specifically on day 14. .

[0050] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. The present invention relates to a method including monitoring the serum phosphate concentration of a subject. The serum phosphate concentration used to determine whether or not this is the first cycle of erdafitinib treatment. During the treatment days between these, specifically on day 14 ± 2 of erdafitinib administration, more specifically, It will be measured on the 14th day.

[0051] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically 1 This is for continuous administration once a day, and the serum phosphate levels of cancer patients are monitored. The use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer. In one embodiment In this context, the serum phosphate concentration used to determine whether to gradually increase the dosage is determined by the erdafitinib treatment. On the treatment days during the first cycle of treatment, specifically on day 14 ± 2 days of erdafitinib administration More specifically, it is measured on the 14th day.

[0052] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. And, the serum phosphate levels of cancer patients are monitored, and it is used for the treatment of cancer in cancer patients. Regarding dafitinib. In one embodiment, serum rib is used to determine whether to escalate. The concentration of erdafitinib salt is determined on the treatment day during the first cycle of erdafitinib treatment, specifically erdafitinib. The measurement is taken 14 ± 2 days after dafitinib administration, more specifically on day 14.

[0053] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. The method includes monitoring the serum phosphate concentration of the subject, but when the serum phosphate concentration is 5.5 m If the level is less than g / dL, the daily dose of erdafitinib administered continuously is preferably The once-daily dose is increased to 9 mg. This includes serum phosphate concentration of 5.5 mg / dL. If the dose is in the range of 5 mg / dL to less than 7 mg / dL, the subject will receive 8 mg daily in a continuous course. Treatment will be limited to moderate. If serum phosphate levels are 7 mg / dL or higher, treatment will be temporarily moderate. The treatment was discontinued, specifically erdafitinib treatment, when the serum phosphate concentration was again less than 7 mg / dL. The dose may be interrupted until the dose reaches 8 mg, or the continuous daily dose may be adjusted to less than 8 mg, specifically Treatment will be temporarily suspended, specifically until the serum phosphate concentration falls below 5.5 mg / dL. In one embodiment, the serum phosphate concentration is set to the first site of erdafitinib treatment. On the treatment days during the cycle, specifically on day 14 ± 2 of erdafitinib administration, more specifically It is measured on the 14th day. In one embodiment, the serum phosphate concentration is, specifically, on the 14th day. On day ±2, more specifically on day 14, the level should be 7 mg / dL or higher, specifically 7 mg / dL. If the serum phosphate concentration is in the range of 7 mg / dL to 9 mg / dL, including [the specified substance], then the serum phosphate concentration is 5.5 Treatment will be temporarily suspended until the level falls below mg / dL, and then erdafitinib treatment will be resumed. The treatment will be restarted daily, specifically once a day, with a continuous dose of 8 mg.

[0054] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0055] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. The method includes monitoring the serum phosphate concentration of subjects, but the serum phosphate concentration is 7 mg / If the dose is less than dL, the daily dose of erdafitinib administered continuously, preferably 1 day The single dose is increased to 9 mg. Serum phosphate concentration is 7 mg / dL or 7 mg / dL. If the concentration is in the range of 9 mg / dL or less, a phosphate binder such as sevelamer may be used in parallel. While treatment is initiated voluntarily, the daily administration of erdafitinib is continuous. The dose, preferably once a day, is increased to 9 mg. In one embodiment, for example, sebe Combination therapy with phosphate binders such as ramar is initiated. Serum phosphate concentration > 9 mg / dL If serum levels rise, treatment will be temporarily discontinued, specifically erdafitinib treatment. Treatment was discontinued until the phosphate concentration was again below 7 mg / dL, and serum phosphate levels were below 7 mg / dL. Once the patient reaches maturity, the continuous daily dose is adjusted to the same or a lower daily dose. In cases of persistent serum phosphate concentrations of 10 mg / dL or higher for an extended period, treatment should be permanently discontinued. Specifically, erdafitinib treatment is permanently discontinued. In one embodiment, serum phosphate The salt concentration is determined on the treatment day during the first cycle of erdafitinib treatment, specifically erdafitinib. It is measured on day 14 ± 2 days after itinib administration, more specifically on day 14. In one embodiment In this case, if the serum phosphate concentration is greater than 9 mg / dL, then the serum phosphate concentration is 7 mg / dL. Treatment is temporarily suspended until the level falls below L, and then erdafitinib treatment is resumed daily. Specifically, it is restarted with 8 mg once daily in a continuous course. In one embodiment, further el Serum phosphate levels during dafitinib administration can be managed according to Table 4.

[0056] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. Monitoring of serum phosphate levels in subjects and FGFR inhibitors in general or specifically erdafitini Regarding methods related to the b, including monitoring of early onset toxicity as indicated by subjects, serum ri If the sodium salt concentration is less than 5.5 mg / dL and no early onset toxicity is observed, The daily dose of erdafitinib administered subsequently, preferably once daily, should be increased to 9 mg. It is done. Serum phosphate concentration of 5.5 mg / dL includes 5.5 mg / dL and ranges from 5.5 mg / dL to 7 mg / dL. If the dose is less than the specified range and no early onset toxicity is observed, the subject will receive 8 mg daily. Treatment is limited to continuous therapy. If serum phosphate levels are 7 mg / dL or higher, treatment is temporary. Treatment was interrupted, specifically erdafitinib therapy, when serum phosphate levels returned to 7 mg / d The dose may be interrupted until it falls below L, or the continuous daily dose may be adjusted to less than 8 mg. Physically, the treatment involves temporarily reducing the serum phosphate concentration to less than 5.5 mg / dL. It is interrupted until. In one embodiment, the serum phosphate concentration is the same as the erdafitinib treatment. During the first cycle, specifically on day 14 ± 2 of erdafitinib administration, Specifically, it is measured on the 14th day. In one embodiment, when the serum phosphate concentration is 7 mg / If the level is above dL, treatment is temporary until the serum phosphate concentration falls below 5.5 mg / dL. The treatment was then interrupted, and subsequently, erdafitinib treatment was administered daily, specifically once a day, for eight consecutive days. The treatment will be resumed at mg.

[0057] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0058] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 8 mg of erdafitinib daily, specifically once daily, for a continuous period. Monitoring of serum phosphate levels in subjects and FGFR inhibitors in general or specifically erdafitini Regarding methods related to the b, including monitoring of early onset toxicity as indicated by subjects, serum ri If the sodium salt concentration is less than 7 mg / dL and no early onset toxicity is observed, continuous The daily dose of erdafitinib administered, preferably once daily, is increased to 9 mg. Serum phosphate concentration including 7 mg / dL, within the range of 7 mg / dL to 9 mg / dL. If present and no early-onset toxicity is observed, in parallel, for example, a phosphorus such as sevelamer may be used. While treatment with an adsorbent is initiated on an optional basis, erdafitinib is administered continuously. The daily dose, preferably once a day, is increased to 9 mg. In one embodiment, for example Combination therapy with phosphate binders such as sevelamer is initiated. When serum phosphate concentration reaches 9 mg / If the level rises above dL, treatment will be temporarily discontinued, specifically erdafitinib treatment. Treatment was discontinued until the serum phosphate concentration was again below 7 mg / dL. When the dose falls below dL, the continuous daily dose is adjusted to the same or a lower daily dose. In this embodiment, the serum phosphate concentration is controlled during the first cycle of erdafitinib treatment. On the day of treatment, specifically on day 14 ± 2 of erdafitinib administration, more specifically on day 14 It is measured in the eye. In one embodiment, when the serum phosphate concentration is greater than 9 mg / dL, Treatment is temporarily suspended until the serum phosphate concentration falls below 7 mg / dL, and then E Rudafitinib treatment will be resumed daily, specifically once a day, at a continuous dose of 8 mg.

[0059] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0060] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 9 mg of erdafitinib daily, specifically once daily, for a continuous period. This includes monitoring the subject's serum phosphate concentration, with daily, specifically once daily, continuous administration of 8 mg. During treatment with erdafitinib, the serum phosphate concentration of the subject was 5.5 This invention relates to a method by which 9 mg is administered to a subject when the level is less than mg / dL. In one embodiment... Furthermore, serum phosphate concentrations are measured on the treatment day during the first cycle of erdafitinib treatment. Physically, it was measured on day 14 ± 2 days after erdafitinib administration, more specifically on day 14. ru.

[0061] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0062] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 9 mg of erdafitinib daily, specifically once daily, for a continuous period. I am receiving treatment with 8 mg of erdafitinib every day, specifically once a day. During this time, if the serum phosphate concentration of the subject is less than 7 mg / dL, or if serum phosphate If the salt concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL, then 9m This describes the method by which g is administered to subjects. The serum phosphate concentration is 7 mg / dL, including 7 mg / If the concentration is in the range of dL to 9 mg / dL or less, for example, when used in combination with phosphate binders such as sevelamer. Oral therapy may be initiated. In one embodiment, combination therapy with a phosphate binder such as sevelamer may be used. Treatment is initiated. In one embodiment, the serum phosphate concentration is controlled by erdafitinib administration. The measurement is taken on the 14th day ± 2 days after administration, specifically on the 14th day.

[0063] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0064] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 9 mg of erdafitinib daily, specifically once daily, for a continuous period. I am receiving treatment with 8 mg of erdafitinib every day, specifically once a day. During this time, the serum phosphate concentration of the subject was less than 5.5 mg / dL, and early onset toxins were detected. This relates to a method of administering 9 mg to a subject when no indication of sexual activity is shown.In one embodiment, And, the serum phosphate concentration is specifically measured on the treatment day during the first cycle of erdafitinib treatment. It is measured approximately 14 ± 2 days after erdafitinib administration, more specifically on day 14. .

[0065] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0066] The present invention relates to a method for treating cancer, which is provided to a subject in need, specifically a cancer patient. This includes administering 9 mg of erdafitinib daily, specifically once daily, for a continuous period. I am receiving treatment with 8 mg of erdafitinib every day, specifically once a day. During this time, if the patient's serum phosphate concentration is less than 7 mg / dL, or if serum phosphate The concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, and is early-onset. This concerns the administration of 9 mg to cancer patients when no biotoxicity is observed. Serum phosphate The concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, and is early-onset. If no biotoxicity is observed, combination therapy with a phosphate binder such as sevelamer may be initiated. It is possible. In one embodiment, combination therapy with a phosphate binder such as sevelamer is initiated. In one embodiment, the serum phosphate concentration is the first cycle of erdafitinib treatment. During the treatment period, specifically on day 14 ± 2 of erdafitinib administration, more specifically It will be measured on the 14th day.

[0067] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0068] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically 1 This is for continuous administration once a day, and the serum phosphate levels of cancer patients are monitored, and serum phosphate If the salt concentration is less than 5.5 mg / dL, administer daily, specifically once a day, continuously. The amount of erdafitinib in the drug will be increased to 9 mg for the treatment of cancer in cancer patients. Regarding the use of erdafitinib for the manufacture of pharmaceuticals. Serum phosphate concentration is 5.5 m If the levels include g / dL and are in the range of 5.5 mg / dL to less than 7 mg / dL, the patient will be 8m Treatment is limited to daily continuous therapy with g. If serum phosphate concentration is 7 mg / dL or higher, Treatment will be temporarily interrupted, specifically erdafitinib treatment, once serum phosphate levels return Treatment may be discontinued until the dose falls below 7 mg / dL, or the continuous daily dose may be adjusted to less than 8 mg. Specifically, the treatment involves temporarily reducing the serum phosphate concentration to 5.5 mg / dL The process is interrupted until it falls below a certain level. In one embodiment, the serum phosphate concentration is erdafiti On the treatment day during the first cycle of nib treatment, specifically on day 14 ± of erdafitinib administration. It is measured on the 2nd, more specifically on the 14th day. In one embodiment, serum phosphate concentration If the level is 7 mg / dL or higher, treatment will continue until the serum phosphate concentration is less than 5.5 mg / dL. The treatment was temporarily interrupted, and then erdafitinib treatment was resumed daily, specifically once a day. Treatment will be restarted with a continuous dose of 8 mg.

[0069] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0070] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically 1 This is for continuous administration once a day, and the serum phosphate levels of cancer patients are monitored, and serum phosphate If the salt concentration is less than 7 mg / dL, daily administration, specifically once a day, is required. The amount of erdafitinib in the drug will be increased to 9 mg, for the treatment of cancer in cancer patients. Regarding the use of erdafitinib for the manufacture of pharmaceuticals. Serum phosphate concentration of 7 mg / dL If the concentration is in the range of 7 mg / dL to 9 mg / dL or less, in parallel, for example, sevelam While treatment with phosphate binders such as the above may be initiated on an optional basis, daily, specifically 1 per day For subsequent administrations, the amount of erdafitinib is increased to 9 mg. In one embodiment... Then, combination therapy with a phosphate binder such as sevelamer is initiated. Serum phosphate concentration If the level rises above 9 mg / dL, treatment will be temporarily discontinued, specifically erdafitin. Treatment is discontinued until serum phosphate levels are again below 7 mg / dL. When the level falls below 7 mg / dL, the continuous daily dose is adjusted to the same or a lower daily dose. In one embodiment, the serum phosphate concentration is set to the first site of erdafitinib treatment. On the treatment days during the cycle, specifically on day 14 ± 2 of erdafitinib administration, more specifically It is measured on the 14th day. In one embodiment, when the serum phosphate concentration is greater than 9 mg / dL In some cases, treatment is temporarily suspended until the serum phosphate concentration falls below 7 mg / dL. Next, erdafitinib treatment was restarted daily, specifically once a day, at a continuous dose of 8 mg. It can be done.

[0071] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0072] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically 1 This is for continuous administration once a day, and the serum phosphate levels of cancer patients are monitored, and in cancer patients The early onset toxicity associated with erdafitinib in general or specifically with FGFR inhibitors is shown. The patient was monitored, serum phosphate levels were less than 5.5 mg / dL, and there was no early onset toxicity. Unless otherwise indicated, eldaf in the drug for continuous administration daily, specifically once a day. The dosage of itinib will be increased to 9 mg, for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. Regarding the use of rudafitinib. 5.5 mg including serum phosphate concentration of 5.5 mg / dL If the level is in the range of 7 mg / dL to less than 7 mg / dL and no early onset toxicity is observed, the patient The patient will be limited to continuous daily treatment of 8 mg. If serum phosphate concentration is 7 mg / dL or higher... In some cases, treatment may be temporarily interrupted, specifically erdafitinib treatment, and serum phosphate Treatment was discontinued until the concentration fell below 7 mg / dL again, or until the continuous daily dose was 8 m The dosage is adjusted to less than g, specifically, the treatment is temporary, specifically, the serum phosphate concentration is 5. The treatment is interrupted until the concentration falls below 5 mg / dL. In one embodiment, the serum phosphate concentration is Specifically, erdafitinib is administered on the treatment day during the first cycle of erdafitinib treatment. It is measured on day 14 ± 2 days, more specifically on day 14. In one embodiment, serum If the phosphate concentration is 7 mg / dL or higher, the serum phosphate concentration must be less than 5.5 mg / dL. Treatment will be temporarily suspended until [a certain period], and then erdafitinib treatment will be resumed daily, specifically [in a specific manner]. The medication will be restarted with 8 mg once daily for a continuous course.

[0073] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0074] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in an 8mg dose, and the medication is taken daily, specifically 1 This is for continuous administration once a day, and the serum phosphate levels of cancer patients are monitored, and in cancer patients The early onset toxicity associated with erdafitinib in general or specifically with FGFR inhibitors is shown. The patient was monitored, serum phosphate concentration was less than 7 mg / dL, and no early onset toxicity was observed. If not possible, take erdafiti in the drug for continuous administration daily, specifically once a day. The amount of nib is increased to 9 mg, for the manufacture of elder for the treatment of cancer in cancer patients. Regarding the use of fitinib. Serum phosphate concentration includes 7 mg / dL and ranges from 7 mg / dL to 9 mg / dL. If the level is below mg / dL and no early onset toxicity is observed, in parallel, for example While treatment with phosphate binders such as sevelamer is initiated on an optional basis, on a daily basis, specific For continuous administration, the dose of erdafitinib is increased to 9 mg once daily. In terms of administration, combination therapy with phosphate binders such as sevelamer is initiated. If the sodium concentration rises above 9 mg / dL, treatment will be temporarily discontinued, specifically for el Dafitinib treatment is discontinued until serum phosphate levels are again below 7 mg / dL. When the phosphate level falls below 7 mg / dL, the continuous daily dose should be the same or lower 1 mg / dL. The daily dose is adjusted. In one embodiment, the serum phosphate concentration is adjusted for erdafitinib treatment. During the first cycle of treatment, specifically on day 14 ± 2 of erdafitinib administration, More specifically, it is measured on the 14th day. In one embodiment, the serum phosphate concentration is 9 mg If the level is above 7 mg / dL, treatment will be temporary until the serum phosphate concentration is less than 7 mg / dL. The treatment was interrupted, and then erdafitinib treatment was administered daily, specifically once a day, for a continuous 8 months. It will resume with g.

[0075] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0076] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in a dose of 9 mg, and the medication is taken daily, specifically 1 This is for continuous administration once a day, specifically 8 mg of L once a day. During treatment with dafitinib, the patient's serum phosphate concentration was 5.5 mg / If the level is less than dL, the drug is administered to cancer patients, the drug is for the treatment of cancer in cancer patients. The present invention relates to the use of erdafitinib for manufacturing. In one embodiment, serum phosphate concentration The degree is, on the treatment day during the first cycle of erdafitinib treatment, specifically erdafitinib The measurement is taken 14 ± 2 days after administration, more specifically on the 14th day.

[0077] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0078] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in a dose of 9 mg, and the medication is taken daily, specifically 1 This is for continuous administration once a day, specifically 8 mg of L once a day. During treatment with dafitinib, the patient's serum phosphate concentration was 7 mg / dL If less than 7 mg / dL, or if the serum phosphate concentration is between 7 mg / dL and 9 mg / If the level is below dL, the drug is administered to the cancer patient for the treatment of cancer. Regarding the use of erdafitinib for the manufacture of pharmaceuticals. Serum phosphate concentration of 7 mg / dL If the concentration is in the range of 7 mg / dL to 9 mg / dL or less, for example, sevelamer Combination therapy with a phosphate adsorbent may be initiated. In one embodiment, for example, a phosphate adsorbent such as sevelamer may be used. Combination therapy with an adsorbent is initiated. In one embodiment, the serum phosphate concentration is set to el On the treatment day during the first cycle of dafitinib treatment, specifically on the day of erdafitinib administration Measurements are taken on day 4 ± 2 days, more specifically on day 14.

[0079] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0080] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in a dose of 9 mg, and the medication is taken daily, specifically 1 This is for continuous administration once a day, specifically 8 mg of L once a day. During treatment with dafitinib, the patient's serum phosphate concentration was 5.5 mg / If the level is less than dL and no early-onset toxicity is observed, the drug is administered to cancer patients. Regarding the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. In this embodiment, the serum phosphate concentration is controlled during the first cycle of erdafitinib treatment. On the day of treatment, specifically on day 14 ± 2 of erdafitinib administration, more specifically on day 14 It is measured by the eye.

[0081] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0082] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. The medication contains erdafitinib in a dose of 9 mg, and the medication is taken daily, specifically 1 This is for continuous administration once a day, specifically 8 mg of L once a day. During treatment with dafitinib, the patient's serum phosphate concentration was 7 mg / dL If less than 7 mg / dL, or if the serum phosphate concentration is between 7 mg / dL and 9 mg / If the level is below dL and no early-onset toxicity is observed, the drug may be administered to cancer patients. Regarding the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. Serum phosphate concentration including 7 mg / dL, within the range of 7 mg / dL to 9 mg / dL. If present and no early onset toxicity is observed, for example, with phosphate binders such as sevelamer Combination therapy may be initiated. In one embodiment, for example, with a phosphate binder such as sevelamer. Combination therapy is initiated. In one embodiment, the serum phosphate concentration is erdafitinib During the first cycle of treatment, specifically on day 14 ± 2 days of erdafitinib administration. More specifically, it is measured on the 14th day.

[0083] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0084] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. The serum phosphate levels of cancer patients were monitored, and serum phosphate levels were below 5.5 mg / dL. In that case, the amount of erdafitinib administered daily, preferably once daily, is 9 Regarding erdafitinib for use in the treatment of cancer in cancer patients, the dosage will be increased to mg. Phosphate concentration of 5.5 mg / dL and within the range of 5.5 mg / dL to less than 7 mg / dL In some cases, the patient is limited to a continuous daily dose of 8 mg. Serum phosphate concentration reaches 7 mg. If the level is above / dL, treatment will be temporarily interrupted, specifically erdafitinib treatment. Treatment may be discontinued until serum phosphate levels fall below 7 mg / dL again, or until continuous daily treatment is discontinued. The dosage is adjusted to less than 8 mg, specifically, the treatment is such that the serum phosphate concentration is 5 It is temporarily suspended until it falls below 0.5 mg / dL. In one embodiment, serum phosphate The concentration of erdafitinib is determined on the treatment day during the first cycle of erdafitinib treatment, specifically on the day of treatment. It is measured 14 ± 2 days after tinib administration, more specifically on day 14. In one embodiment... Furthermore, if the serum phosphate concentration is 7 mg / dL or higher, the serum phosphate concentration is 5.5 mg Treatment is temporarily suspended until the level falls below / dL, and then erdafitinib treatment is resumed daily. Specifically, treatment will be restarted with a continuous dose of 8 mg once daily.

[0085] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0086] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. Furthermore, serum phosphate levels in cancer patients were monitored, and if the serum phosphate level was less than 7 mg / dL, In cases where, or if the serum phosphate concentration is 7 mg / dL or between 7 mg / dL and 9 mg / dL If the following range is observed, erdafitinib is administered daily, preferably once daily, continuously. The dosage of erdafitinib for use in cancer treatment in cancer patients will be increased to 9 mg. Serum phosphate concentration including 7 mg / dL, within the range of 7 mg / dL to 9 mg / dL. In some cases, combination therapy with a phosphate binder such as sevelamer may be initiated. One embodiment In this case, combination therapy with phosphate binders such as sevelamer is initiated. Serum phosphate If the concentration rises above 9 mg / dL, treatment will be temporarily interrupted, specifically with erdafi Tinib treatment is discontinued until serum phosphate levels fall below 7 mg / dL again. When the salt level falls below 7 mg / dL, the continuous daily dose should be the same or lower than the daily dose. It is adjusted. In one embodiment, the serum phosphate concentration is adjusted for the first treatment of erdafitinib. On the treatment day between cycles, specifically on day 14 ± 2 days of erdafitinib administration, more Physically, it is measured on the 14th day. In one embodiment, the serum phosphate concentration is 9 mg / dL If the level is excessive, treatment will be temporarily suspended until the serum phosphate concentration is less than 7 mg / dL. Next, erdafitinib treatment was administered daily, specifically once a day, in a continuous dose of 8 mg. It will be opened.

[0087] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0088] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. The serum phosphate levels of cancer patients were monitored, and FGFR inhibitors were shown to be effective in cancer patients. Early onset toxicity related to erdafitinib, either general or specifically, is monitored, and serum phosphate concentration is monitored. If the dose is less than 5.5 mg / dL and no early onset toxicity is observed, then daily doses are recommended. In cancer patients, the amount of erdafitinib administered once daily in a continuous course is increased to 9 mg. Regarding erdafitinib for use in the treatment of cancer. Serum phosphate concentration of 5.5 mg The levels include 5.5 mg / dL and are in the range of less than 7 mg / dL, and the early onset toxicity is If no adverse reaction is observed, the patient will continue with a continuous daily dose of 8 mg. Serum phosphate concentration If the dose is 7 mg / dL or higher, treatment will be temporarily discontinued, specifically erdafitin. Treatment is discontinued until serum phosphate levels fall below 7 mg / dL again, or daily The continuous dose is adjusted to less than 8 mg, specifically the treatment is serum phosphate The process is temporarily interrupted until the salt concentration falls below 5.5 mg / dL. In one embodiment, blood The concentration of the phosphate solution is determined on the treatment day during the first cycle of erdafitinib treatment, specifically: It is measured 14 ± 2 days after erdafitinib administration, more specifically on day 14. In the administration method, if the serum phosphate concentration is 7 mg / dL or higher, the serum phosphate concentration Treatment will be temporarily suspended until the level falls below 5.5 mg / dL, and then erdafitinib treatment will be resumed. Treatment will be resumed daily, specifically once a day, with a continuous dose of 8 mg.

[0089] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0090] This invention relates to the administration of erdafitinib at a dose of 8 mg daily, specifically once daily for several consecutive days. The serum phosphate levels of cancer patients were monitored, and FGFR inhibitors were shown to be effective in cancer patients. Early onset toxicity related to erdafitinib, either general or specifically, is monitored, and serum phosphate concentration is monitored. If the serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 mg / dL, then 7 mg / If the concentration is in the range of dL to 9 mg / dL or less, administer daily, preferably once daily, continuously. The dose of erdafitinib will be increased to 9 mg for use in the treatment of cancer in cancer patients. Regarding erdafitinib. Serum phosphate concentration includes 7 mg / dL and ranges from 7 mg / dL to 9 mg / dL. If the level is below mg / dL, combination therapy with phosphate binders such as sevelamer is available. It can be initiated. In one embodiment, combination therapy with a phosphate binder such as sevelamer can be initiated. Treatment will be initiated. If serum phosphate levels rise above 9 mg / dL, treatment will be temporarily interrupted. Specifically, erdafitinib treatment is used when serum phosphate levels return to below 7 mg / dL. If treatment is interrupted until serum phosphate levels fall below 7 mg / dL, the daily continuous dose will be the same. The daily dose is adjusted to 1 or lower. In one embodiment, the serum phosphate concentration is 1 On the treatment day during the first cycle of dafitinib treatment, specifically on the day of erdafitinib administration It is measured on day 4 ± 2 days, more specifically on day 14. In one embodiment, serum phosphorus If the acid salt concentration is greater than 9 mg / dL, treatment should be performed until the serum phosphate concentration is less than 7 mg / dL. The treatment will be temporarily suspended until it is completed, and then erdafitinib treatment will be administered daily, specifically once a day. Treatment is restarted with 8 mg consecutively.

[0091] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0092] The present invention relates to erdafitinib for use in the treatment of cancer in cancer patients, and specifically, daily Specifically, while receiving continuous treatment with 8 mg of erdafitinib once daily, the aforementioned If the patient's serum phosphate concentration is less than 5.5 mg / dL, erdafitinib is administered for 9 months. It is administered in a dose of g daily, specifically once a day, for continuous use in treating cancer in cancer patients. This relates to erdafitinib for the purpose of [details omitted]. In one embodiment, the serum phosphate concentration is [details omitted]. On the treatment day during the first cycle of dafitinib treatment, specifically on the day of erdafitinib administration Measurements are taken on day 4 ± 2 days, more specifically on day 14.

[0093] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0094] The present invention relates to erdafitinib for use in the treatment of cancer in cancer patients, and specifically, daily Specifically, while receiving continuous treatment with 8 mg of erdafitinib once daily, the aforementioned If the patient's serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 mg / If the dL is included and the range is between 7 mg / dL and 9 mg / dL or less, erdafitinib is, It is administered daily, specifically once a day, in a dose of 9 mg, for continuous use in the treatment of cancer in cancer patients. Regarding erdafitinib for use. Contains 7 mg of serum phosphate when serum phosphate concentration is 7 mg / dL. If the range is from / dL to 9 mg / dL or less, for example, with phosphate binders such as sevelamer. Combination therapy may be initiated. In one embodiment, for example, with a phosphate binder such as sevelamer. Combination therapy is initiated. In one embodiment, the serum phosphate concentration is erdafitinib During the first cycle of treatment, specifically on day 14 ± 2 days of erdafitinib administration. More specifically, it is measured on the 14th day.

[0095] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0096] The present invention relates to erdafitinib for use in the treatment of cancer in cancer patients, and specifically, daily Specifically, while receiving continuous treatment with 8 mg of erdafitinib once daily, the aforementioned The patient's serum phosphate concentration was less than 5.5 mg / dL, and no early onset toxicity was observed. If not, erdafitinib is administered at a dose of 9 mg daily, specifically once a day, for continuous periods. The present invention relates to erdafitinib for use in the treatment of cancer in cancer patients. In one embodiment, In this context, serum phosphate concentrations were measured on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. It can be done.

[0097] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0098] The present invention relates to erdafitinib for use in the treatment of cancer in cancer patients, and specifically, daily Specifically, while receiving continuous treatment with 8 mg of erdafitinib once daily, the aforementioned If the patient's serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 mg It contains 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, and has no early onset toxicity whatsoever. If not specified, erdafitinib is administered at a dose of 9 mg daily, specifically once a day, consecutively. This relates to erdafitinib, administered to cancer patients for use in the treatment of cancer. The sodium chloride concentration is in the range of 7 mg / dL to 9 mg / dL, and If no early-onset toxicity is observed, combination therapy with phosphate binders such as sevelamer may be considered. It can be initiated. In one embodiment, combination therapy with a phosphate binder such as sevelamer can be initiated. It is initiated. In one embodiment, the serum phosphate concentration is the first erdafitinib treatment. On the treatment day between cycles, specifically on day 14 ± 2 days of erdafitinib administration, more Physical measurements are taken on the 14th day.

[0099] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0100] In one embodiment of the present invention, the serum phosphate concentration (the amount of erdafitinib is 8 m daily) is To determine if the dose can be increased from g to 9 mg daily, erdafitinib plasma is used. It is evaluated when the concentration and serum phosphate levels reach steady state levels.

[0101] In one embodiment of the present invention, the dose of erdafitinib is changed from 8 mg per day to 9 mg per day. The serum phosphate concentration used to determine whether it can be increased is the first dose of erdafitinib treatment. On the treatment day during one cycle, specifically around day 14 ± 2 of erdafitinib treatment , specifically on the 14th day of erdafitinib treatment (the 14th day of cycle 1 of erdafitinib treatment) is evaluated. In one embodiment, the cycle is 21 days. In one embodiment it is 28 days.

[0102] The daily amount of erdafitinib referred to herein can be administered by one pharmaceutical composition or by two or more pharmaceutical compositions. The pharmaceuticals referred to herein can include one pharmaceutical composition or two or more pharmaceutical compositions. In one embodiment, an 8 mg dose of erdafitinib can be administered as two formulations, specifically two tablets each containing 4 mg of erdafitinib. In one embodiment, a 9 mg dose of erdafitinib can be administered as three formulations, specifically three tablets each containing 3 mg of erdafitinib.

[0103] The present invention is a method for treating cancer, a) administering 8 mg of erdafitinib daily, specifically once a day, continuously to a subject in need thereof, specifically a cancer patient; b) measuring the serum phosphate concentration of the subject on the treatment days during the first cycle of erdafitinib treatment, specifically on the 14th day ± 2 days of erdafitinib administration, more specifically on the 14th day; c-1) If the serum phosphate concentration is less than 5.5 mg / dL, erdafitinib is administered continuously in an amount of 9 mg daily, specifically once a day; c-2) If the serum phosphate concentration is in the range including 5.5 mg / dL and less than 7 mg / dL, erdafitinib is further administered continuously in an amount of 8 mg daily, specifically once a day; c-3) If serum phosphate concentration is 7 mg / dL or higher, erdafitinib treatment is prescribed. The treatment will be temporarily discontinued until the phosphate concentration falls below 5.5 mg / dL, and then Eldaf will be administered. Itinib treatment should be restarted daily, specifically once a day, with a continuous dose of 8 mg. Regarding methods including

[0104] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0105] The present invention is a method for treating cancer, a) To subjects who need it, specifically cancer patients, 8 mg of erdafitinib daily. Specifically, it should be administered once a day, continuously. b) The subject's serum phosphate concentration was measured on the treatment day during the first cycle of erdafitinib treatment. Specifically, on day 14 ± 2 days after erdafitinib administration, more specifically on day 14. It is something to do; c-1) If the serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 If the amount includes mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, erdafitini The drug is administered daily, specifically once a day, in a dose of 9 mg; and serum phosphorus For example, if the acid salt concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, For example, combination therapy with phosphate binders such as sevelamer is initiated on an optional basis; c-2) If serum phosphate concentration is greater than 9 mg / dL, erdafitinib treatment is required. The treatment was temporarily discontinued until the phosphate concentration fell below 7 mg / dL, and then erdafitini was administered. Treatment should be restarted with a continuous dose of 8 mg daily, specifically once a day. Regarding methods including

[0106] In one embodiment, the serum phosphate concentration during further erlotinib administration can be managed according to Table 4 as follows.

[0107] The present invention relates to a method for treating cancer, comprising: a) administering 8 mg of erlotinib daily, specifically once a day, continuously, to a subject in need thereof, specifically a cancer patient; ; b) measuring the serum phosphate concentration of the subject on the treatment days during the first cycle of erlotinib treatment, specifically on the 14th day ± 2 days of erlotinib administration, more specifically on the 14th day; ; ; c-1) If the serum phosphate concentration is less than 5.5 mg / dL and no early-onset toxicity is shown, erlotinib is administered continuously in an amount of 9 mg daily, specifically once a day; ; ; c-2) If the serum phosphate concentration is in the range of 5.5 mg / dL to less than 7 mg / dL and no early-onset toxicity is shown, erlotinib is further administered continuously in an amount of 8 mg daily, specifically once a day; ; ; c-3) If the serum phosphate concentration is 7 mg / dL or higher and no early-onset toxicity is shown, erlotinib treatment is temporarily interrupted until the serum phosphate concentration is less than 5.5 mg / dL, and then erlotinib treatment is resumed daily, specifically once a day, continuously at 8 mg ; ; ; and related methods.

[0108] In one embodiment, the serum phosphate concentration during further erlotinib administration can be managed according to Table 3 as follows.

[0109] The present invention relates to a method for treating cancer, comprising: a) To subjects who need it, specifically cancer patients, 8 mg of erdafitinib daily. Specifically, it should be administered once a day, continuously. b) The subject's serum phosphate concentration was measured on the treatment day during the first cycle of erdafitinib treatment. Specifically, on day 14 ± 2 days after erdafitinib administration, more specifically on day 14. It is something to do; c-1) Serum phosphate concentration is less than 7 mg / dL and no early onset toxicity is shown. If not present, or if serum phosphate concentration is between 7 mg / dL and 9 mg / dL, including 7 mg / dL. If the condition is within the specified range and no early onset toxicity is observed, erdafitinib is administered at a dose of 9 mg. The dosage is administered daily, specifically once a day, continuously; and the serum phosphate concentration is 7 m If the concentration includes g / dL and is in the range of 7 mg / dL to 9 mg / dL or less, for example, sevelamer Combination therapy with phosphate binders such as these may be initiated at the discretion of the patient; c-2) Serum phosphate concentration is greater than 9 mg / dL, and no early onset toxicity is observed. In this case, erdafitinib treatment is temporary until the serum phosphate concentration is less than 7 mg / dL. The treatment was then interrupted, and subsequently, erdafitinib treatment was administered daily, specifically once a day, for eight consecutive days. Restarting in mg Regarding methods including

[0110] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0111] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. There is, a) The medication contains erdafitinib in an 8 mg dose, and the medication is taken daily, specifically 1 mg per day. This is for the purpose of administering a series of doses; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) If serum phosphate concentration is less than 5.5 mg / dL, daily, specifically 1 per day For subsequent administrations, the amount of erdafitinib in the medication was increased to 9 mg; c-2) Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and 7 mg / dL If the dose is less than the specified range, the patient will receive 8 mg daily, specifically once daily, as part of a continuous treatment regimen. Stop; c-3) If serum phosphate concentration is 7 mg / dL or higher, erdafitinib treatment is prescribed. The treatment will be temporarily discontinued until the phosphate concentration falls below 5.5 mg / dL, and then Eldaf will be administered. Itinib treatment will be restarted daily, specifically once a day, with a continuous dose of 8 mg, for Eldafi. Regarding the use of tinib.

[0112] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0113] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. There is, a) The medication contains erdafitinib in an 8 mg dose, and the medication is taken daily, specifically 1 mg per day. This is for the purpose of administering a series of doses; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) If the serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 If the amount includes mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, then, daily, specifically The amount of erdafitinib in the medication for continuous administration is increased to 9 mg once daily. Furthermore, serum phosphate concentration is 7 mg / dL and between 7 mg / dL and 9 mg / dL or less. If the condition is within the range, combination therapy with a phosphate binder such as sevelamer may be initiated at the discretion of the patient. re; c-2) If serum phosphate concentration is greater than 9 mg / dL, erdafitinib treatment is required. The treatment was temporarily discontinued until the phosphate concentration fell below 7 mg / dL, and then erdafitini was administered. Treatment will be restarted with erdafitinib at a continuous dose of 8 mg daily, specifically once a day. Regarding use.

[0114] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0115] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. There is, a) The medication contains erdafitinib in an 8 mg dose, and the medication is taken daily, specifically 1 mg per day. This is for the purpose of administering a series of doses; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) Serum phosphate concentration is less than 5.5 mg / dL and no early onset toxicity is shown. If not possible, take erdafiti in the drug for continuous administration daily, specifically once a day. The amount of nib was increased to 9 mg; c-2) Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and 7 mg / dL If the dose is less than the specified range and no early onset toxicity is observed, the patient should take 8 mg daily. Physically, the treatment is limited to one session per day; c-3) Serum phosphate concentration is 7 mg / dL or higher, and no early onset toxicity is shown. If not, erdafitinib treatment will continue until the serum phosphate concentration is less than 5.5 mg / dL. The treatment was temporarily interrupted, and then erdafitinib treatment was resumed daily, specifically once a day, consecutively. Regarding the use of erdafitinib, it will be restarted at a typical 8 mg dose.

[0116] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0117] This invention relates to the use of erdafitinib for the manufacture of pharmaceuticals for the treatment of cancer in cancer patients. There is, a) The medication contains erdafitinib in an 8 mg dose, and the medication is taken daily, specifically 1 mg per day. This is for the purpose of administering a series of doses; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) Serum phosphate concentration is less than 7 mg / dL and no early onset toxicity is shown. If not present, or if serum phosphate concentration is between 7 mg / dL and 9 mg / dL, including 7 mg / dL. If it falls within the range and no early onset toxicity is shown, then daily, specifically once a day, The amount of erdafitinib in the medication for continuous administration is increased to 9 mg; and serum When the phosphate concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less. For example, combination therapy with phosphate binders such as sevelamer may be initiated on an optional basis; c-2) Serum phosphate concentration is greater than 9 mg / dL, and no early onset toxicity is observed. In this case, erdafitinib treatment is temporary until the serum phosphate concentration is less than 7 mg / dL. The treatment was interrupted, and then erdafitinib treatment was administered daily, specifically once a day, for eight consecutive days. Regarding the resumption of erdafitinib use at mg dose.

[0118] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0119] The present invention a) Erdafitinib is administered daily at a dose of 8 mg, specifically once daily for several consecutive days; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) If the serum phosphate concentration is less than 5.5 mg / dL, erdafitinib is 9 It is administered in mg increments daily, specifically once a day, continuously; c-2) Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and 7 mg / dL If the dose is less than 8 mg, erdafitinib is administered daily, specifically once a day. and administered continuously; c-3) If serum phosphate concentration is 7 mg / dL or higher, erdafitinib treatment is prescribed. The treatment will be temporarily discontinued until the phosphate concentration falls below 5.5 mg / dL, and then Eldaf will be administered. itinib treatment is restarted daily, specifically once a day, with a continuous dose of 8 mg, for cancer patients. Regarding erdafitinib for use in the treatment of [condition].

[0120] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0121] The present invention a) Erdafitinib is administered daily at a dose of 8 mg, specifically once daily for several consecutive days; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) If the serum phosphate concentration is less than 7 mg / dL, or if the serum phosphate concentration is 7 If the amount includes mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, erdafitini The drug is administered daily, specifically once a day, in a dose of 9 mg; and serum phosphorus For example, if the acid salt concentration includes 7 mg / dL and is in the range of 7 mg / dL to 9 mg / dL or less, For example, combination therapy with phosphate binders such as sevelamer is initiated on an optional basis; c-2) If serum phosphate concentration is greater than 9 mg / dL, erdafitinib treatment is required. The treatment was temporarily discontinued until the phosphate concentration fell below 7 mg / dL, and then erdafitini was administered. The treatment for cancer in cancer patients is restarted with 8 mg daily, specifically once a day, in a continuous course. Regarding erdafitinib for use in the medical field.

[0122] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0123] The present invention a) Erdafitinib is administered daily at a dose of 8 mg, specifically once daily for several consecutive days; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) Serum phosphate concentration is less than 5.5 mg / dL and no early onset toxicity is shown. If not, erdafitinib is administered at a dose of 9 mg daily, specifically once a day, for several consecutive days. Administered; c-2) Serum phosphate concentration of 5.5 mg / dL and between 5.5 mg / dL and 7 mg / dL If the value is less than 8m and no early onset toxicity is observed, erdafitinib is considered safe for use at 8m The dose is administered in grams daily, specifically once a day, continuously thereafter; c-3) Serum phosphate concentration is 7 mg / dL or higher, and no early onset toxicity is shown. If not, erdafitinib treatment will continue until the serum phosphate concentration is less than 5.5 mg / dL. The treatment was temporarily interrupted, and then erdafitinib treatment was resumed daily, specifically once a day, consecutively. Erdafitinib for use in the treatment of cancer in cancer patients will be restarted at a dose of 8 mg. .

[0124] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 3. It can be managed according to the following.

[0125] The present invention a) Erdafitinib is administered daily at a dose of 8 mg, specifically once daily for several consecutive days; b) The patient's serum phosphate concentration was on the treatment day during the first cycle of erdafitinib treatment. Specifically, measurements were taken on day 14 ± 2 days after erdafitinib administration, and more specifically on day 14. re; c-1) Serum phosphate concentration is less than 7 mg / dL and no early onset toxicity is shown. If not present, or if serum phosphate concentration is between 7 mg / dL and 9 mg / dL, including 7 mg / dL. If the condition is within the specified range and no early onset toxicity is observed, erdafitinib is administered at a dose of 9 mg. The dosage is administered daily, specifically once a day, continuously; and the serum phosphate concentration is 7 m If the concentration includes g / dL and is in the range of 7 mg / dL to 9 mg / dL or less, for example, sevelamer Combination therapy with phosphate binders such as these may be initiated at the discretion of the patient; c-2) Serum phosphate concentration is greater than 9 mg / dL, and no early onset toxicity is observed. In this case, erdafitinib treatment is temporary until the serum phosphate concentration is less than 7 mg / dL. The treatment was interrupted, and then erdafitinib treatment was administered daily, specifically once a day, for eight consecutive days. Regarding erdafitinib for use in the treatment of cancer in cancer patients, which will be restarted at mg.

[0126] In one embodiment, serum phosphate concentrations during further erdafitinib administration are shown in Table 4. It can be managed according to the following.

[0127] The treatment and methods of use described herein are based on phosphate concentration as a pharmacodynamic marker. While based on this, please understand that these may be modified or discontinued based on toxicity. In the embodiments, the treatment or use is modified or discontinued as described in Table 1.

[0128] [Table 1]

[0129] If erdafitinib is discontinued, specifically for one consecutive week due to drug-related toxicity. If the above is interrupted, it should be resumed at the same dose level or at the first reduction after recovery from toxicity. It can be reintroduced at the dose level. In one embodiment, erdafitinib dose reduction level The details are as shown in Table 2. The second dose reduction is the second occurrence of drug-related toxicity. Later, the specifics may be implemented as described in Table 2.

[0130] [Table 2]

[0131] When treatment with erdafitinib or its administration should be discontinued, for example, erdafitinib The level of toxicity is acceptable (in the case of non-hematological toxicity, grade 1 or lower, or return to baseline). If a drug-related adverse event that does not resolve on its own requires a suspension of treatment for longer than 28 days. The decision to continue treatment if the patient has benefited from it rests with the doctor. The physician must demonstrate that continued treatment with erdafitinib is in the patient's best interest. It should be understood that this is possible. Erdafitinib is being administered at a reduced dose, and this dose is low If the adverse events that led to the reduction have completely resolved, the dosage should be reduced if the patient is still benefiting from the treatment. If this occurs, the dosage may be increased again to a higher level, and the physician should consider increasing the erdafitinib dosage again. It can demonstrate what is most beneficial for the patient.

[0132] For patients with any grade of toxicity (grades 1-4), symptomatic treatment should be administered if applicable. You should understand that you must give.

[0133] In one embodiment, treatment with erdafitinib is interrupted as described herein. If serum phosphate levels are monitored until they return to the indicated level, then the serum phosphate assessment The price check will be conducted at least weekly.

[0134] In one embodiment, treatment with erdafitinib is used for hyperphosphatemia as described herein. If interrupted for this reason, the interruption will last approximately 7 days, specifically 7 days.

[0135] Serum phosphate levels, specifically on the treatment day during the first cycle of erdafitinib treatment. Specifically, on day 14 ± 2 days after erdafitinib administration, more specifically on day 14. The pharmacokinetics used to determine whether to escalate the starting dose of erdafitinib at 8 mg. When measured as a medical marker, phosphate levels should be monitored further during erdafitinib treatment. It should be understood that this can be viewed as such. In one embodiment, clinical management of serum phosphate concentration This will be carried out as shown in Table 3.

[0136] [Table 3]

[0137] In one embodiment, the clinical management of serum phosphate concentration is carried out as shown in Table 4. ru.

[0138] [Table 4]

[0139] To manage elevated phosphate levels, limiting daily phosphate intake may be required. It should be understood.

[0140] To manage elevated phosphate levels, patients may also take, for example, sevelamer phosphate (p It should be understood that it may be necessary to take phosphate binders such as phosphates. be.

[0141] The evaluation of tumor response reported herein is Response Evaluation. Criteria in Solid Tumors (RECIST) version 1.1 It was carried out according to .

[0142] This invention relates to erdafitinib formulations and the drug regimens described herein. This also includes information about the packaging, such as patient leaflets.

[0143] In one embodiment, the cancer referred to herein is mediated by FGFR kinase. It is cancer.

[0144] In one embodiment, the cancer is bladder cancer.

[0145] In one embodiment, the cancer is hepatocellular carcinoma.

[0146] In one embodiment, the cancer is squamous cell carcinoma.

[0147] In one embodiment, the cancer is squamous cell NSCLC (non-small cell lung cancer), specifically selected It is a squamous cell NSCLC (non-small cell lung cancer) with FGFR gene mutations, specifically This refers to squamous cell NSCLC with FGFR gene alterations, selected after relapse following standard treatment (non- This is a cancer treatment for patients with small cell lung cancer.

[0148] In one embodiment, the cancer is hepatocellular carcinoma having FGF19 amplification or overexpression.

[0149] In one embodiment, the cancer is bile duct cancer, specifically advanced or metastatic bile duct cancer.

[0150] In one embodiment, the cancer is urothelial carcinoma.

[0151] In one embodiment, the cancer is metastatic or surgically unresectable urothelial carcinoma.

[0152] In one embodiment, the cancer is progressive urothelium having a selected FGFR gene mutation. Cancer, specifically, selected FGFR that has progressed in or after a previous treatment. This is a cancer treatment for patients with advanced urothelial carcinoma that has genetic mutations.

[0153] In one embodiment, the cancer is lung cancer, specifically non-small cell lung cancer.

[0154] In one embodiment, cancer is adenoid cystic carcinoma, mucoepidermoid carcinoma, follicular thyroid carcinoma, breast cancer, Ewing's cancer. Sarcoma, small round cell bone tumors ), synovial sarcoma, glioblastoma multiforme, pilocytic astrocytoma, lung cancer, clear cell renal cell carcinoma, bladder The choice is made from cancer, prostate cancer, ovarian cancer, or colorectal cancer.

[0155] In one embodiment, the cancer is multiple myeloma, specifically t(4;14) translocation-positive multiple myeloma. It is multiple myeloma.

[0156] In one embodiment, the cancer is nonmuscle-invasive bladder cancer, specifically characterized by FGFR genomic changes (e.g., For example, nonmuscle-invasive bladder cancer with translocation, fusion, and / or mutation.

[0157] In one embodiment, the cancer is esophageal cancer or head and neck cancer.

[0158] In one embodiment, the cancer is gastric cancer.

[0159] In one embodiment, the cancer referred to herein is a FGFR genomic alteration (e.g., translocation). Cancers with fusion and / or mutations, specifically erdafitinib-sensitive FGFR Cancers with genomic changes (e.g., translocations, fusions, and / or mutations), e.g., FGFR genome Bladder cancer with alterations (e.g., translocations, fusions, and / or mutations), or FGFR genomic alterations. Urothelial carcinoma with (e.g., translocation, fusion, and / or mutation) or FGFR genomic alterations Metastatic or unresectable urinary tract with (e.g., translocation, fusion, and / or mutation) Bile ducts with epithelial carcinoma or FGFR genomic changes (e.g., translocations, fusions, and / or mutations) Cancer, or progressive young with FGFR genomic changes (e.g., translocations, fusions, and / or mutations) Alternatively, it could be metastatic cholangiocarcinoma.

[0160] In one embodiment, the cancer referred to herein is the following fused FGFR3:TACC3 v1;FGFR3:TACC3 v3;FGFR3:TACC3 intron;FGFR 3:BAIAP2L1;FGFR2:AFF3;FGFR2:BICC1;FGFR2: Changes selected from CASP7;FGFR2:CCDC6 and FGFR2:OFD1 It is cancer.

[0161] In one embodiment, the cancer referred to herein is FGFR3-TACC3 fusion or metastasis. Cancers with a translocation, for example, bladder cancer with an FGFR3-TACC3 translocation, or FGFR3- Urothelial carcinoma with TACC3 translocation, or metastatic urothelial carcinoma with FGFR3-TACC3 translocation Alternatively, it could be urothelial carcinoma that is not surgically resectable.

[0162] In one embodiment, the cancer referred to herein is the following FGFR3 gene mutation: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, FGFR 3. This is a cancer with a change selected from Y373C.

[0163] In one embodiment, the cancer referred to herein is the following FGFR3 gene mutation: FGFR3 R248C, FGFR3 S249C, FGFR3 G370C, FGFR 3. Bladder cancer having at least one Y373C, or urothelial carcinoma, or metastatic or This is urothelial carcinoma that is not surgically resectable.

[0164] In one embodiment, a subject requiring treatment for cancer as referred to herein, specifically For the treatment of cancer in cancer patients or as a method of treating cancer, the FGFR of the tumor is selected. Having a nom-like change, and during or after at least one line of prior systemic chemotherapy, Or, the treatment failed within 12 months of neoadjuvant or adjuvant chemotherapy. (failed), or chemotherapy not performed but cisplatin unsuitable, metastatic or surgical It is for use in or treatment of patients with unresectable urothelial carcinoma.

[0165] In one embodiment, a subject requiring treatment for cancer as referred to herein, specifically The use of luminal clusters for the treatment of cancer in cancer patients or for methods of treating cancer is lumin Use for patients with al cluster I subtype urothelial carcinoma or for the treatment of patients It is a treatment.

[0166] In one embodiment, erdafitinib is administered as a pharmaceutically acceptable salt.

[0167] In a preferred embodiment, erdafitinib (base) is administered.

[0168] In one embodiment, erdafitinib is equivalent to 8 mg base equivalent or 9 mg salt It is administered as a pharmaceutically acceptable salt in an amount equivalent to the base equivalent.

[0169] Salts can be obtained, for example, by reacting erdafitinib in a suitable acid and solvent. It can be prepared.

[0170] Acid addition salts can be formed by either inorganic or organic acids. An example of an acid addition salt is vinegar. Acids, hydrochloric acid, hydroiodic acid, phosphoric acid, nitric acid, sulfuric acid, citric acid, lactic acid, succinic acid, maleic acid Inic acid, malic acid, isethionic acid, fumaric acid, benzenesulfonic acid, toluenesulfonic acid Methanesulfonic acid (mesylate), ethanesulfonic acid, naphthalenesulfonic acid, valeric acid , acetic acid, propionic acid, butanoic acid, malonic acid, glucuronic acid, and lactobionic acid There are salts formed by acids selected from a group. Another group of acid addition salts includes acetic acid, adipyl acetate, and others. Ascorbic acid, aspartic acid, citric acid, DL-lactic acid, fumaric acid, gluconic acid Glucuronic acid, hippuric acid, hydrochloric acid, glutamic acid, DL-malic acid, methanesulfone There are salts formed from acids, sebacic acid, stearic acid, succinic acid, and tartaric acid.

[0171] In one embodiment, erdafitinib is administered in the form of a solvate. The term "solvate" refers to the physical association of erdafitinib with one or more solvent molecules. This physical association involves various degrees of ionic and covalent bonding, including hydrogen bonding. In certain cases, solvates are formed when, for example, one or more solvent molecules are incorporated into the crystal lattice of a crystalline solid. If present, isolation may be possible. The term "solvate" refers to a solution phase and an isolated substance. This shall include both active and solvate forms. Non-limiting examples of solvents that can form solvates include: , water, isopropanol, ethanol, methanol, DMSO, ethyl acetate, acetic acid, or Examples include ethanolamine.

[0172] Solvates are well known in medicinal chemistry. They are used in the process of preparing substances (for example, Regarding the purification of these substances, considerations include the storage of the substance (e.g., its stability) and the ease of handling the substance. It is important for this to be formed as part of the isolation or purification step in chemical synthesis. Many. Those skilled in the art can use standard and long-established techniques to prepare a given compound. The isolation or purification conditions used to determine whether a hydrate or other solvate was formed can be used to determine whether a hydrate or other solvate was formed. Yes, it is possible. Examples of such techniques include thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), X-ray crystallography (e.g., single-crystal X-ray crystallography or X-ray powder diffraction) and solid-state NMR (SS- There is NMR (also known as magic angle spinning NMR or MAS-NMR). These techniques, like NMR, IR, HPLC, and MS, are standard analytical methods performed by skilled chemists. It is part of the means. Alternatively, a person skilled in the art would know to use a blot containing the required amount of solvent for a particular solvate. By utilizing the crystallization conditions, solvates can be intentionally formed. Subsequently, the standard method described above can be used. The method can be used to confirm whether a solvate has been formed. Any complex (e.g., cyclo (Inclusion complexes or clathrates with compounds such as rhodextrin, or complexes with metals) It is included.

[0173] In one embodiment, the treatment cycle as defined herein is a 28-day cycle.

[0174] In one embodiment, the patient described herein, specifically a cancer patient, or a patient treated with erdafitinib The subjects requiring treatment are human beings.

[0175] As used herein in relation to numerical values, the term "about" has the usual meaning in the context of numerical values. It shall have a taste. Where necessary, the word "approximately" means a value of ±10%, ±5%, or ± It can be replaced by 2%, or ±1%.

[0176] All documents cited herein are incorporated as a whole by reference. [Examples]

[0177] An ongoing Phase 2 multicenter open-label trial (NCT02365597) Phase 2 multicenter open-label trials select FGFR gene mutations (FGFR translocations or mutations). In subjects with metastatic or surgically unresectable urothelial carcinoma (with different characteristics), Eldafi This study is being conducted to evaluate the efficacy and safety of tinib.

[0178] The trial included a screening phase (molecular screening at any point before the first dose and This includes the clinical screening within 30 days of the first dose, the treatment period, and the post-treatment follow-up period. The treatment period includes the time from the first dose to the follow-up visit at the end of treatment. The observation period is when the subject Death, withdrawal of consent, loss of trackability, or termination of the study, whichever comes first. It will probably be extended until then.

[0179] The experimental treatment is administered in 28-day cycles. Prior to interim analysis 1, two treatment regimens were... Yes. The patient received the following two regimens until the regimen was selected for further testing. Participants were randomly assigned in a 1:1 ratio to a 28-day cycle according to: Regimen 1 (10 mg once daily). Missing (7 days administered / 7 days); Regimen 2 (6 mg once daily, consecutively). After interim analysis 1, E Pharmacokinetic and pharmacodynamic models relating rudafitinib administration regimens to serum phosphate concentrations Based on the ring results, the protocol will be modified to administer a starting dose of 8 mg / day in continuous infusions. The regimen was increased to (regmen 3), and on the 14th day, the target serum phosphate concentration was not reached at that point (serum Patients with a phosphate concentration of less than 5.5 mg / dL and who have not experienced any treatment-related adverse events. In patients who did not respond, the dose was gradually increased to 9 mg / day. Observed toxicity (treatment-related adverse events (TRA)) A dose reduction based on E)) was predicted in the protocol.

[0180] Please refer to Figure 1 for the Phase 2 trial scheme.

[0181] patient The patients included were subject to Response Evaluation Criteria. In Solid Tumors version 1.1, patients with measurable urothelial carcinoma have been diagnosed. He was an adult.

[0182] Patients utilize a custom assay, from formalin-fixed, paraffin-embedded tumor samples. According to the central lab testing of RNA, at least one FGFR2 / FGFR3 mutation was detected. The presence of mutations or fusions was required.

[0183] The patient received at least one line of prior systemic chemotherapy, or thereafter, or 12 The disease had progressed with less than 1 month of neoadjuvant or adjuvant chemotherapy.

[0184] Patients who were deemed unsuitable for cisplatin based on protocol criteria and who had not received chemotherapy were accepted. Cisplatin unsuitability was determined by: 1) 24-hour urine measurement of 60 mL / min / 1.73 m 2 1) Glomerular filtration rate less than 2) Calculation by Cockcroft-Gault; or 3) Grade 2 or higher Peripheral neuropathy (Common Terminology Criteria for Adverse Events [CTCAE] Version 4.0 (National Cancer Institute.CTCAE v4.0.NCI,NIH,DHHS .May 29,2009.NIH publication#09-7473:200 9.) It was based on renal dysfunction as defined by this.

[0185] Eastern Cooperative Oncology Group (ECOG) A performance status of 0-2 was requested.

[0186] Previously, there was no limit on the number of treatment lines.

[0187] Previous immunotherapies (e.g., treatment with PD-L1 / PD-1 inhibitors) were accepted.

[0188] The patient has sufficient bone marrow, liver, and kidney function (creatinine clearance ≥ 40 mL / min). It was required to have [this characteristic].

[0189] Despite medical management, phosphate levels remain persistently above the upper limit of normal, control Patients with poor cardiovascular disease, brain metastases, known hepatitis B or C, or known HIV. Those individuals were excluded.

[0190] endpoint The primary endpoint of this ongoing trial is the selected regimen (regimen 3). This is the objective response rate to ). Secondary endpoints include progression-free survival (P FS), duration of response (DoR), overall survival, safety, predictive biomarker evaluation, and drug There is dynamics.

[0191] evaluation Patients should be screened within 30 days of screening, once every 6 weeks for the first 3 months, and then again for the next 9 months. Radiographic imaging was performed once every 12 weeks, and then once every 4-6 months until the disease progressed. Its effectiveness was evaluated using [this method].

[0192] Tumor response is RECIST version 1.1 (Eisenhauer EA et a Treatment according to l., Eur J Cancer, 2009, 45(2), 228-247) Evaluated by the principal investigator.

[0193] Safety will be assessed by the principal investigator through a medical review of the AE report and measurement of vital signs. Values, physical examination, clinical tests, ECOG performance status, and other safety assessment results The results were evaluated sequentially.

[0194] result Baseline characteristics and efficacy data were collected from May 7, 2015 to June 10, 2017. Registered and effectiveness can be evaluated according to RECIST 1.1 (response evalu This is represented for 170 patients who were considered to be able (Table 5).

[0195] Safety data are defined as safety analysis data from patients who received at least one dose of the investigational treatment. Regarding the elephant population (N=207, registered from May 7, 2015 to December 5, 2017) As of December 5, 2017, the median treatment duration was 4.2 months, and the median treatment duration for patients was I was receiving 5 cycles of erdafitinib.

[0196] During the screening period, 21% of patients had FGFR mutations or fusions that met the selection criteria. I had it.

[0197] Across all dosages, 89% had received prior treatment with at least one line of systemic chemotherapy. It was progressing.

[0198] [Table 5]

[0199] Across all usages, the established objective response rate was 35% (95% CI, 28%-43%). Yes, and the highest rate was cured with continuous erdafitinib at 8 mg / day in regimen 3. The patient was treated (Table 6). The confirmed disease control rate was 76% among all patients. Yes, the majority of patients treated with continuous erdafitinib at 8 mg / day had tumors. A decrease in volume was observed (44 / 59 [75%] showed a decrease in the sum of the target lesion diameters; Figure 2). .

[0200] The median progression-free survival was 5.1 months, and continuous 8 mg / day in regimen 3 The longest response time was observed among patients treated with erdafitinib (Table 6).

[0201] The median duration of response in the erdafitinib group (regmen 3) receiving 8 mg / day of continuous treatment was 5 It has been 4 months, and many responses are ongoing (Table 6).

[0202] [Table 6]

[0203] Time until response In a subset of 59 patients receiving regimen 3, the median time to response was 1.41. It was a month, ranging from 1.1 to 5.5 months.

[0204] Across all usages, 94% (n=195) of patients reported TRAE; most of these The grades were 1 or 2 (Table 7).

[0205] 33% (n=69) of patients reported grade 3 TRAEs, and 0.5% (n=1) of patients reported grade 3 TRAEs. The patient reported a Grade 4 TRAE, and there were no treatment-related deaths.

[0206] AE was manageable.

[0207] Recommendations for preventing major adverse events associated with erdafitinib treatment: • A low-phosphate diet was recommended for all patients to reduce the risk of hyperphosphatemia (1 day (Dietary phosphate intake of 600-800 mg per person). • To reduce the risk of skin reactions, apply an alcohol-free softening and moisturizing cream. Also, avoid unnecessary exposure to sunlight, soap, scented products, and hot baths. This was recommended. To reduce the risk of nail-related complications, it is recommended that patients keep their hands and feet clean and trim their nails. It was recommended.

[0208] management • Hyperphosphatemia (>5.5 mg / dL) is managed with phosphate binders when there is a medical reason. It was done. • For dry skin, apply additional topical creams such as ammonium lactate, salicylic acid, or zinc oxide. The condition was managed with ointment. Nail function was managed with topical nail strengtheners; in severe cases, antibiotics or silver nitrate were prescribed. It was done.

[0209] TRAEs associated with the class of FGFR inhibitors were typically grade 1 or 2. ;Across all uses, two patients reported retinopathy (Grade 2 [n=1] and Grade 2). 3 [n=1]).

[0210] Across all dosage regimens, 22 patients (11%) discontinued treatment as a result of TRAE (Traumatic Emission Assessment). The most common TRAEs that led to the cessation of symptoms were asthenia, dry mouth, and redness and sensation in the palms and soles. It was a syndrome of insufficiency.

[0211] [Table 7]

Claims

1. A method of treating cancer, comprising administering to a subject in need thereof, particularly a cancer patient, a serum phosphate Salt concentration in the range of 5.5 mg / dL to less than 7 mg / dL, including 5.5 mg / dL or in the range of 5.5 mg / dL to 9 mg / dL inclusive. The method comprises administering an amount of erdafitinib to a patient in need thereof.

2. the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL; The method of claim 1 , wherein the range is less than 1000 ppm.

3. Serum phosphate concentration between 5.5 mg / dL and less than 7 mg / dL, including 5.5 mg / dL or in the range of 5.5 mg / dL to 9 mg / dL, inclusive Use of erdafitinib for the manufacture of a medicament for the treatment of cancer in an amount in the range For.

4. the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL; The use according to claim 3, wherein the range is less than 1000 mg / kg.

5. Erdafitinib was administered to patients with a serum phosphate concentration of 5.5 mg / dL. in the range of 5.5 mg / dL to less than 7 mg / dL or inclusive of 5.5 mg / dL 1. An eltrombopag for use in the treatment of cancer, wherein the eltrombopag is administered in an amount such that the eltrombopag is in the range of 0.1 to 9 mg / dL or less. Dafitinib.

6. the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL; Erdafitinib for use according to claim 4, wherein the range is less than 100 mg / kg.

7. A method of treating cancer, comprising administering to a subject in need thereof, particularly a cancer patient, 8 mg of estrogen. A method comprising administering rudafitinib continuously every day, specifically once a day.

8. Use of erdafitinib for the manufacture of a medicament for the treatment of cancer, said medicament comprising and the pharmaceutical product contains erdafitinib in an amount of 8 mg, and the pharmaceutical product is administered daily, specifically once a day. Use of erdafitinib, which is for continuous administration.

9. Erdafitinib is administered daily, specifically once daily, in an amount of 8 mg. Erdafitinib for use in the treatment of

10. The cancer is urothelial cancer, bladder cancer, hepatocellular carcinoma, squamous cell carcinoma, or lung cancer.

10. The method or use according to any one of 9.

11. 11. The method of claim 10, wherein the cancer is metastatic or surgically unresectable urothelial carcinoma. is used.

12. 11. The method or use of claim 10, wherein the cancer is advanced or metastatic cholangiocarcinoma.

13. 1. A method of treating cancer, comprising: a) Subjects in need thereof, specifically cancer patients, receive 8 mg of erdafitinib daily. , specifically once daily and continuously; b) measuring the subject's serum phosphate concentration during the first cycle of erdafitinib treatment; Specifically, on day 14 ± 2 of erdafitinib administration, more specifically on day 14 Measuring; c-1) When the serum phosphate concentration is less than 5.5 mg / dL, erdafitinib , administered continuously daily, specifically once a day, in an amount of 9 mg; c-2) the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL If the blood glucose level is in the range of less than 1 / 4 of a stool, erdafitinib is administered daily, specifically in an amount of 8 mg / day. one additional dose administered consecutively; c-3) When the serum phosphate concentration is 7 mg / dL or more, the erdafitinib treatment Therapy is temporarily discontinued until serum phosphate levels are below 5.5 mg / dL, and then Erdafitinib treatment is resumed daily, specifically at a continuous dose of 8 mg once daily. A method comprising:

14. Use of erdafitinib for the manufacture of a medicament for the treatment of cancer in a cancer patient. a) the pharmaceutical product contains erdafitinib in an amount of 8 mg, and the pharmaceutical product is administered daily, specifically is for continuous once-daily administration; b) the patient's serum phosphate concentration is higher than that of the patient on day 1 of treatment during the first cycle of erdafitinib treatment Specifically, it was measured on day 14 ± 2 of erdafitinib administration, more specifically on day 14. It is determined; c-1) If the serum phosphate concentration is less than 5.5 mg / dL, daily, specifically 1 The amount of erdafitinib in the drug product for continuous administration once daily is increased to 9 mg. ； c-2) the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL If the patient is in the range of less than 1000 dL, the patient should be administered 8 mg daily, specifically once daily, continuously. Stay in treatment; c-3) When the serum phosphate concentration is 7 mg / dL or more, the erdafitinib treatment Therapy is temporarily discontinued until serum phosphate levels are below 5.5 mg / dL, and then Erdafitinib treatment is resumed daily, specifically at 8 mg once daily. For.

15. Erdafitinib for use in treating cancer in a cancer patient. a) erdafitinib is administered continuously daily, specifically once daily, in an amount of 8 mg; b) the patient's serum phosphate concentration is higher than that of the patient on day 1 of treatment during the first cycle of erdafitinib treatment Specifically, it was measured on day 14 ± 2 of erdafitinib administration, more specifically on day 14. It is determined; c-1) When the serum phosphate concentration is less than 5.5 mg / dL, erdafitinib , administered continuously daily, specifically once a day, in an amount of 9 mg; c-2) the serum phosphate concentration is 5.5 mg / dL to 7 mg / dL, including 5.5 mg / dL If the blood glucose level is in the range of less than 1 / 4 of a stool, erdafitinib is administered daily, specifically in an amount of 8 mg / day. one additional dose administered consecutively; c-3) When the serum phosphate concentration is 7 mg / dL or more, the erdafitinib treatment Therapy is temporarily discontinued until serum phosphate levels are below 5.5 mg / dL, and then Erdafitinib treatment is resumed daily, specifically at 8 mg once daily. Rudafitinib.

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