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Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer

A prostate cancer and anti-androgen technology, applied in the direction of anti-tumor drugs, organic active ingredients, medical preparations containing active ingredients, etc.

Pending Publication Date: 2021-09-07
ARAGON PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a clear unmet medical need for alternative treatment options for mCSPC

Method used

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  • Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer
  • Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer
  • Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0221] Example 1: Apalutamide plus androgens in subjects with metastatic hormone-sensitive prostate cancer (mCSPC) Phase 3 randomized, placebo-controlled, double-blind study of resection therapy (ADT) versus ADT

[0222] Target

[0223] main target

[0224] To determine whether the addition of apalutamide to androgen deprivation therapy (ADT) provides superior efficacy in prolonging radiographic progression-free survival (rPFS) or overall survival (OS) in subjects with mCSPC.

[0225] secondary goal

[0226] Evaluate clinically relevant improvements caused by the addition of apalutamide to ADT, including delays in pain progression and opioid use for prostate cancer, skeletal-related events, and the need for cytotoxic chemotherapy;

[0227] Characterize the safety of adding apalutamide to ADT for subjects with mCSPC;

[0228] · Characterization of the population pharmacokinetics (PK) and pharmacodynamics (PD) of apalutamide;

[0229] assess the concentration of le...

Embodiment 2

[0514] Example 2: Final FDA Approved Drug Product Labeling

[0515] FDA approved ERLEADA on September 17, 2019 TM The following drug product labels for (apalutamide), ERLEADA TM is a reference listed drug for apalutamide.

[0516]

[0517]

[0518] Full Prescribing Information

[0519] 1. Indications and usage

[0520] ERLEADA is indicated for the treatment of patients with:

[0521] Metastatic castration-sensitive prostate cancer (mCSPC)

[0522] Non-metastatic castration-resistant prostate cancer (nmCRPC)

[0523] 2 Dosage and Administration

[0524] 2.1 Recommended dosage

[0525] The recommended dose of ERLEADA is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablet whole. ERLEADA can be taken with or without food.

[0526] Patients should also be receiving concomitant gonadotropin-releasing hormone (GnRH) analogs or should have undergone bilateral orchiectomy.

[0527] 2.2 Dosage adjustment

[0528] If the patient experience...

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Abstract

Described herein are methods of treating metastatic castration-sensitive prostate cancer with anti-androgens, including but not limited to, 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N- methylbenzamide.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims US Provisional Patent Application 62 / 901,694, filed September 17, 2019; US Provisional Patent Application 62 / 836,920, filed April 22, 2019; US Provisional Patent Application, filed April 12, 2019 62 / 833,371; US ​​Provisional Patent Application 62 / 822,312, filed March 22, 2019; US Provisional Patent Application 62 / 803,096, filed February 8, 2019; and US Provisional Patent Application, January 30, 2019 The benefit of patent application 62 / 798,836, all of which are incorporated herein by reference in their entirety. technical field [0003] Disclosed herein are methods of treating metastatic castration-sensitive prostate cancer with antiandrogens including, but not limited to, 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl) -8-oxo-6-thio-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. Background technique [0004] For men, prostate cancer is the second most frequently diagnosed cancer and t...

Claims

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Application Information

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IPC IPC(8): A61K31/4155A61K31/4166A61K31/4439A61P5/28A61P35/00
CPCA61K31/4439A61K31/4166A61K31/4155A61P35/00A61P5/28
Inventor M·K·余
Owner ARAGON PHARMA INC
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