Astellas Pharma and Medivation today announced that FDA has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.
The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency on April 2, 2014.
The FDA's acceptance of the sNDA triggers a milestone payment to Medivation under its collaboration agreement with Astellas.