EU approves Janssen's prostate cancer drug

Janssen-Cilag has announced that the European Commission (EC) has approved its late stage prostate cancer drug Zytiga (abiraterone acetate) for marketing. The approval follows an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Zytiga is a novel, once-daily, oral, androgen biosynthesis inhibitor, which when combined with prednisone or prednisolone, acts as a treatment for metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, commented that Zytiga "gives new hope to men who are suffering from this late stage of prostate cancer" and that it helps them "live longer with a better quality of life and less pain."