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Janssen Submits NDA to US FDA for Apalutamide for Treatment of Non-Metastatic Castration-Resistant Prostate Cancer.

M2 PHARMA-October 12, 2017-Janssen Submits NDA to US FDA for Apalutamide for Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

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- Horsham, Pennsylvania-based pharmaceutical company Janssen Biotech, Inc. has submitted a New Drug Application to the US Food and Drug Administration for apalutamide, an investigational, next generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer, the company said.

This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen despite receiving continuous androgen deprivation therapy.

The primary endpoint of this study was metastasis free survival (MFS), the time from randomization to first evidence of confirmed metastasis, or time to death.

Apalutamide is an investigational, next generation oral androgen receptor inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.

Janssen, a pharmaceutical company of Johnson and Johnson (NYSE: JNJ), works to find new and better ways to prevent, intercept, treat, and cure disease.

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Publication:M2 Pharma
Date:Oct 12, 2017
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