FDA expands label for Zytiga

Johnson & Johnson (NYSE:JNJ) said FDA approved a new indication for Zytiga abiraterone acetate (CB7630) in combination with prednisone to treat metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on data from a Phase III LATITUDE trial (see BioCentury, Jun. 16, 2017).

Zytiga is approved in the U.S. and EU to treat metastatic castration-resistant prostate cancer (CRPC) in combination with prednisone and in the EU to treat newly diagnosed high-risk metastatic hormone-sensitive prostate cancer in combination with prednisone or prednisolone...