Xtandi enzalutamide regulatory update

FDA approved once-daily Xtandi enzalutamide well ahead of the oral prostate cancer drug's Nov. 22 PDUFA date. Xtandi is indicated to treat metastatic castration-resistant prostate cancer (CRPC) in patients previously treated with docetaxel. The partners will co-commercialize the product, with a launch planned for mid-September. The wholesale acquisition cost will be $7,450 for a 30-day supply. In clinical trials, the median duration of treatment was 8.3 months, which would cost about $62,000.

The partners also said EMA accepted for review an MAA for the oral androgen receptor antagonist. Medivation will receive a $30 million payment triggered by the FDA approval and an additional $5 million triggered by EMA's acceptance of the MAA. Medivation is required to share 10% of the milestone payments with the University of California, Los Angeles under a 2005 deal for the university's small molecule androgen receptor antagonists. ...