J&J's Janssen-Cilag's ZYTIGA Receives Positive EU Recommendation

J&J's

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA® (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.1 If endorsed by the European Commission, the recommendation would expand the indication for ZYTIGA®, which is currently approved for use in combination with prednisone/prednisolone to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.