Astellas submits EU application to expand Xtandi's label

Medivation Inc. (NASDAQ:MDVN) and partner Astellas Pharma Inc. (Tokyo:4503) said Astellas submitted an MAA to EMA to expand the label of Xtandi enzalutamide to include treatment of metastatic castration-resistant prostate cancer (CRPC) patients who are asymptomatic or mildly symptomatic and in whom chemotherapy is not yet clinically indicated. Last month, Astellas submitted an sNDA to FDA to add treatment of chemotherapy-naïve CRPC patients to the U.S. label for Xtandi. 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. ...