BioCentury
ARTICLE | Company News

Astellas submits Japan application for enzalutamide

May 25, 2013 12:53 AM UTC

Astellas Pharma Inc. (Tokyo:4503) and Medivation Inc. (NASDAQ:MDVN) said the pharma submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for enzalutamide to treat prostate cancer. FDA approved the oral androgen receptor antagonist as Xtandi last August for metastatic castration-resistant prostate cancer (CRPC) in men whose disease has progressed on or after docetaxel therapy. In April, EMA's CHMP recommended approval of an MAA for Xtandi in the FDA-approved indication. The companies partnered to develop and commercialize Xtandi in 2009 (see BioCentury Extra, April 26). ...