Enzalutamide Gets Priority Review for Castrate-resistant Prostate Cancer


Get Permission

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. ■



Advertisement

Advertisement



Advertisement