Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer

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Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted Priority Review Designation.

Enzalutamide is an oral, once-daily androgen receptor signaling inhibitor. The investigational agent inhibits androgen receptor signaling in three distinct ways: it inhibits (1) testosterone binding to androgen receptors; (2) nuclear translocation of androgen receptors; and (3) DNA binding and activation by androgen receptors.

In the phase III AFFIRM trial, common side effects observed more frequently in enzalutamide- compared with placebo-treated patients included fatigue, diarrhea, and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the enzalutamide group than in the placebo group. ■




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