On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi 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 (ADT) in whom chemotherapy is not yet clinically indicated.

Europe now joins the United States in allowing Xtandi to be given to men who have not yet had chemotherapy.

The rationales for this amendment are derived from the pivotal phase III PREVAIL study that demonstrated that Xtandi improved outcomes for men with advanced prostate cancer who have not received chemotherapy. These findings were:

• 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.

“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.”

Astellas has indicated that they intend to launch Xtandi in the chemotherapy-naïve setting in the first European countries, including the UK beginning December 2014.

Joel T. Nowak, M.A., M.S.W.