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Astellas, Medivation (MDVN) Receive Positive CHMP Opinion on XTANDI

April 26, 2013 8:53 AM EDT Send to a Friend
Astellas Pharma Europe Ltd., the European Headquarters of Tokyo-based Astellas Pharma Inc., and Medivation, Inc. (Nasdaq: MDVN) have received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission (EC) approval 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 is a novel, once-daily, oral androgen receptor inhibitor. It inhibits multiple steps in the androgen receptor (AR) signaling pathway, which has been shown preclinically to decrease cancer cell growth and can induce cancer cell death (apoptosis). The positive CHMP opinion is based on results from the phase III AFFIRM study which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival compared to placebo, with a median survival of 18.4 months in the enzalutamide group versus 13.6 months in the placebo group, an advantage of 4.8 months [hazard ratio (HR) = 0.631]. The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints. The most common adverse reaction leading to treatment discontinuation was seizure, which occurred in 0.9% of the XTANDI-treated patients compared to none (0%) of the placebo-treated patients.

The CHMP's positive recommendation will be reviewed by the European Commission (EC), which has authority to approve medicines for the European Union. Astellas anticipates a final decision from the EC shortly, as this usually occurs approximately 60 days after a CHMP recommendation.

Professor Johann de Bono, Professor of Experimental Cancer Medicine, Head of Drug Development Unit, and of the Prostate Cancer Targeted Therapy Group, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, comments: “This is an important development in prostate cancer therapeutics that will provide a critically important new treatment option for patients with advanced prostate cancer. Enzalutamide has a major impact on patient survival from this common disease, and will hopefully become a key component of prostate cancer treatment initially in late stage disease following chemotherapy.”




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