EC grants marketing authorization for XTANDI capsules for treating advanced prostate cancer

Jun 24 2013

Astellas Pharma Europe Ltd., the European Headquarters of Tokyo-based Astellas Pharma Inc. (TSE:4503), and Medivation, Inc. (Nasdaq: MDVN) announced that following the regulatory review process by the European Medicines Agency (EMA) and a positive opinion from the Committee for Medicinal Products for Human Use on April 25, 2013, the European Commission (EC) has granted the marketing authorization for XTANDI^™ (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

“Enzalutamide, an oral drug, improves the quality of life and survival time for patients who have an advanced form of this common disease and is generally well tolerated.”

"This is a major development in prostate cancer therapeutics that will provide an important new treatment option for patients with advanced prostate cancer following chemotherapy," said Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust.

Professor de Bono, who is also Head of the Drug Development Unit, a joint facility between The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, located at The Royal Marsden, added: "Enzalutamide, an oral drug, improves the quality of life and survival time for patients who have an advanced form of this common disease and is generally well tolerated."

The EC grant of the marketing authorization applies in all European Union (EU) Member States, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Dr. Erik Briers, Executive Director, European Cancer Patient Coalition (ECPC) and member of the strategic committee of Europa Uomo comments: "Unfortunately prostate cancer can evolve into a life threatening castration resistant metastatic condition where treatment options are needed because all patients are not identical. A new treatment such as enzalutamide is one more option that will give selected patients a new chance if other options fail. Patients with advanced prostate cancer are very concerned about their quality of life, so they favor treatments with fewer side effects. Enzalutamide has been shown to be generally well tolerated."

The European Commission approval triggers a $15 million milestone payment to Medivation under its collaboration with Astellas, which is reflected in Astellas' current fiscal year (from 1^st April 2013 to 31^st March 2014) financial forecast.