CHMP recommends label expansion for J&J prostate cancer drug Zytiga
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...
BCIQ Target Profiles
Cytochrome P450 17 alpha-hydroxylase/C17, 20 lyase (CYP17) (CYP17A)