MAA for Enzalutamide is Submitted to EMA by Astellas

Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have previously been treated with docetaxel-based chemotherapy.

The submission is based on Phase 3 AFFIRM trial of enzalutamide in post-chemotherapy prostate cancer patients in which seizure was reported in less than 1% of enzalutamide-treated patients.

The study reported that 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.

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

A new drug application has been submitted in the US, where priority review of the compound has been requested.