Astellas : XTANDI Approved In Europe For Treatment Of Men With MCRPC

(RTTNews) - Astellas Pharma Europe Ltd. announced that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI). Enzalutamide 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 in whom chemotherapy is not yet clinically indicated.

The Marketing Authorisation approval is based on results from the pivotal phase III PREVAIL study which demonstrate that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.

Enzalutamide was approved by the EC in June 2013 for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy. The new indication makes enzalutamide available for men in whom chemotherapy is not yet clinically indicated. Astellas expects to launch enzalutamide in the chemotherapy-naïve setting in the first European countries, including the UK, from December 2014.

In October 2009, Medivation Inc. (MDVN) and Astellas entered into a global agreement to jointly develop and commercialise enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialise enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercialising enzalutamide outside the United States.