7 April 2016 - Medivation and Astellas Pharma Inc. announced today that the CHMP of the EMA has issued a positive opinion recommending approval of a type II variation to include data from the head-to-head TERRAIN trial of enzalutamide versus bicalutamide in the European label for Xtandi (enzalutamide) capsules.

Xtandi is approved in the European Union for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

For more details, go to: http://investors.medivation.com/releasedetail.cfm?ReleaseID=963955