Xiya Reagent:XTANDI(enzalutamide) Now Approved in Europe for the

XTANDI(enzalutamide) Now Approved in Europe for the Treatment of Men with Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

Enzalutamide significantly reduced the risk of radiographic progression or death by 81% compared with placebo

Enzalutamide demonstrated a significant impact on overall survival compared to placebo

Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo

Astellas Pharma Europe Ltd. today announced that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI™).1 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.1

“Enzalutamide provides a viable treatment option for a broad population of men with mCRPC, regardless of age, or their readiness for chemotherapy, which provides a meaningful period of time during which men have their disease controlled without the need for chemotherapy”, said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of Urology and Professor of Physiology, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. “The decision from the European Commission to approve enzalutamide, an effective and well tolerated alternative to chemotherapy, is a very important milestone for men with prostate cancer that has advanced.”

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.2

Compared with placebo, enzalutamide reduced the risk of death by 29% (HR=0.71; p<0.001) and the risk of radiographic progression or death by 81% (HR=0.19; p<0.001). Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo (28.0 months versus 10.8 months, respectively; HR=0.35; p<0.001).2

The most common clinically relevant adverse events among the enzalutamide population as compared with placebo-treated patients in the PREVAIL trial included fatigue, hot flush and hypertension. Hypertension was observed in 13% of enzalutamide versus 4% of placebo-treated patients. Grade 3 or higher cardiac adverse events were reported in 3% of enzalutamide versus 2% of placebo-treated patients. One patient (0.1%) out of the 871 patients treated with enzalutamide, and one patient (0.1%) out of 844 patients receiving placebo experienced a seizure.2

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.3 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.