The great news for for our brothers in Europe is that Xtandi (Enzalutamide) has been approved for use in the European Union (EU) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after chemotherapy (docetaxel).
Following the regulatory review process by the European Medicines Agency (EMA) and a positive review from the Committee for Medicinal Products for Human Use (CHMP) on 25th April 2013, the European Commission (EC) has granted the marketing authorization 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 signalling inhibitor (androgen receptor blockade) that inhibits multiple steps in the androgen receptor (AR) signaling pathway. The interruption of the androgen signaling has been shown to decrease cancer cell growth and induce cancer cell death (apoptosis).
Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “This is a major development in prostate cancer therapeutics that will provide an important new treatment option for patients with advanced prostate cancer following chemotherapy.”
The EU granted its authorization 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