Astellas Pharma Inc., Medivation, Inc. Release: Positive CHMP Opinion for Xtandi (Enzalutamide) in Advanced Prostate Cancer
Published: Apr 26, 2013
CHERTSEY, England & SAN FRANCISCO, CA--(BUSINESS WIRE)--Today, Astellas Pharma Europe Ltd., the European Headquarters of Tokyo-based Astellas Pharma Inc. (TSE:4503), 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.1
Enzalutamide is a novel, once-daily, oral androgen receptor signalling inhibitor.2 It inhibits multiple steps in the androgen receptor (AR) signalling pathway, which has been shown to decrease cancer cell growth and can induce cancer cell death (apoptosis).2 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.3
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