FDA approves Xtandi for chemotherapy-naïve CRPC

FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) to expand the label of Xtandi enzalutamide to include treatment of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). The approval triggers a $90 million milestone payment from Astellas to partner Medivation Inc. (NASDAQ:MDVN).

An MAA to add chemotherapy-naïve CRPC to Xtandi's European label is under review. The oral androgen receptor antagonist is already approved in more than 35 countries, including the U.S. and EU, for CRPC patients previously treated with docetaxel. ...