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. ■