Abiraterone (Zytiga®) approved in the EU for treatment of metastatic castration-resistant prostate cancer prior to chemotherapy

Source: BioSpace Area: News According to BioSpace, the European Commission (EC) has approved an extension to the license of abiraterone to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. Abiraterone has until now has been approved only for use in men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.   The approval follows a positive opinion issued by the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency in November 2011 (see link below). This was based on positive data from the Phase III COU-AA-302 study, which was published in the New England Journal of Medicine in December 2012 (see link below for NeLM summary).
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news