Medivation, Inc. (MDVN) and Astellas Pharma Inc. (ALPMF.PK) announced that the U.S. Food and Drug Administration or FDA has granted approval to XTANDI capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Medivation and Astellas expect to make XTANDI available to patients in the United States in mid-September 2012.
Medivation said that the FDA accepted the XTANDI New Drug Application or NDA on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act or PDUFA action date of November 22, 2012.
XTANDI is an oral, once-daily androgen receptor inhibitor. The efficacy and safety of XTANDI were assessed in a randomized, placebo-controlled, multicenter phase 3 clinical trial. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either XTANDI orally at a dose of 160 mg once daily or placebo, the company said.
Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. The primary endpoint of the trial was overall survival.
XTANDI-treated patients had a statistically-significant improvement in median overall survival compared to the placebo group. 18.4 months in the XTANDI group versus 13.6 months in the placebo group, Medivation noted.
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