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Medivation-Astellas EAP for enzalutamide gets FDA clearance

The US Food and Drug Administration (FDA) has allowed Medivation and Astellas to proceed with an Expanded Access Program (EAP) for the investigational therapy enzalutamide (formerly MDV3100) under a treatment protocol in the US.

As part of the EAP, enrollment of eligible men with metastatic castration-resistant prostate cancer previously treated with docetaxel chemotherapy has been started.

The study, sponsored by Medivation and Astellas Pharma Global Development, will see the participation of investigators at approximately 75 centers in the US to provide expanded access to enzalutamide until the drug becomes commercially available, after FDA approval.

Medivation and Astellas submitted a New Drug Application for enzalutamide to the FDA on 21 May 2012.

An oral, once-daily investigational agent Enzalutamide inhibits androgen receptor signaling in three distinct ways, which include testosterone binding to androgen receptors, nuclear translocation of androgen receptors, and DNA binding and activation by androgen receptors.

In the Phase 3 AFFIRM trial, enzalutamide was well tolerated, while common side effects observed more frequently as compared with placebo-treated patients included fatigue, diarrhea and hot flush.