Janssen-Cilag says EC approves broader indication for ZYTIGA Janssen-Cilag International announced that the European Commission has approved an extension to the license of the oral, once-daily medication ZYTIGA. The approved broader indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.Until now, ZYTIGA with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen. The ECís decision follows recommendations from the Committee for Medical Products for Human Use of the European Medicines Agency that were based on data from the Phase III COU-AA-302 study.
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