On March 18, 2014 Astellas and Medivation reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy (Press release Astellas, MAR 18, 2014, View Source [SID:1234500305]). 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. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.