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