Enzalutamide recommended for approval in the European Union (EU) for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy 1

Chertsey, England and San Francisco, CA; 26 April, 2013: 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

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 at The Institute of Cancer Research, London, and Head of the Drug Development Unit at The 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 quality of life and 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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Committee for Medicinal Products for Human Use (CHMP). Summary of opinion (initial authorisation). Xtandi http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002639/WC500142493.pdf (last accessed April 2013)
Scher H I, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study. The Lancet 2010;375(9724):1437-46
Scher H I, et al. MDV3100, an Androgen Receptor Signaling Inhibitor (ARSI), Improves Overall Survival in Patients With Prostate Cancer Post Docetaxel; Results From the Phase 3 Affirm Study. Presented at ASCO-GU, 02 February 2012
Globocan 2008. WHO Europe Region (EURO); Prostate cancer incidence, mortality and prevalence worldwide in 2008European Union (EU-27): estimated incidence, mortality and 5-year prevalence: men. 
Beltran H. et al, Collaborative Review – Prostate Cancer New Therapies for Castration-Resistant Prostate Cancer: Efficacy and Safety, European Urology 2011; 60(2):279-290
Moul JW. The evolving definition of advanced prostate cancer. Rev Urol. 2004; 6(Suppl 8): S10–S17.
Macmillan Cancer Support, Hormonal therapy for advanced prostate cancer. Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Prostate/Treatmentforadvancedprostatecancer/Hormonaltherapy.aspx (last accessed March 2013)
Yap T A, et al. The changing therapeutic landscape of castration-resistant prostate cancer, Nat. Rev. Clin. Oncol 2011;8(10):597-610
SMPC. Astellas Pharma Europe Ltd. Data on file

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