On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.
Europe now joins the United States in allowing Xtandi to be given to men who have not yet had chemotherapy.
The rationales for this amendment are derived from the pivotal phase III PREVAIL study that demonstrated that Xtandi improved outcomes for men with advanced prostate cancer who have not received chemotherapy. These findings were: