Astellas Pharma Inc. and Medivation Inc. announced 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.
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.
Date: March 18, 2014
Filed Under: Drug Discovery