The sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of 18 September 2014.
Currently, XTANDI is approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.
The sNDA is based on the results from the Phase III PREVAIL trial which evaluated XTANDI compared to placebo in over 1,700 chemotherapy-naïve mCRPC patients.
The trial was designed to assess enzalutamide at a dose of 160mg taken orally once daily versus placebo.
A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency (EMA) in April 2014.
According to the firms, the FDA’s acceptance of the sNDA triggers a milestone payment to Medivation under its collaboration agreement with Astellas.
The randomized, double-blind, placebo-controlled, multi-national Phase III PREVAIL trial enrolled about 1,700 patients at sites in the US, Canada, Europe, Australia, Russia, Israel and Asian countries including Japan.
Co-primary endpoints of the trial were overall survival and radiographic progression-free survival.