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Janssen Biotech submits NDA with the US FDA for apalutamide for non-metastatic castration-resistant prostate cancer.

M2 EQUITYBITES-October 12, 2017-Janssen Biotech submits NDA with the US FDA for apalutamide for non-metastatic castration-resistant prostate cancer


Health company Janssen Biotech Inc said on Wednesday that it has filed its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for apalutamide for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).

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, added the company.

This US FDA submission is based on the company's 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 (PSA) despite receiving continuous androgen deprivation therapy (ADT).

The company said the primary endpoint of the SPARTAN study results, which will be presented at a future medical meeting, was metastasis free survival (MFS), which is the time from randomisation to first evidence of confirmed metastasis, or time to death.

Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease.These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs.

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Publication:M2 EquityBites (EQB)
Date:Oct 12, 2017
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