Tokyo and San Francisco, CA – June 3, 2013 – Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (Nasdaq: MDVN) today announced that after a priority review, Health Canada has approved XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy.
XTANDI® (enzalutamide) capsules is an oral, once-daily androgen receptor inhibitor. XTANDI was approved by the U.S. Food and Drug Administration on August 31, 2012 for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel (chemotherapy). On April 26, 2013, the Companies received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending European Commission approval for XTANDI. An application for marketing approval was submitted to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer on May 24, 2013.