BioCentury
ARTICLE | Clinical News

CHMP recommends label expansion for J&J prostate cancer drug Zytiga

December 1, 2017 9:43 PM UTC

EMA's CHMP recommended approval of a label expansion for Zytiga abiraterone acetate (CB7630) from Johnson & Johnson (NYSE:JNJ) to include treatment of newly diagnosed, high-risk, hormone-sensitive metastatic prostate cancer in adult men in combination with androgen deprivation therapy (ADT) and prednisone or prednisolone.

Zytiga is already approved in the EU to treat metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone or prednisolone. The drug's current label supports its use after surgical or medical castration with standard ADT or chemotherapy has failed...