FDA approves Zytiga for metastatic high-risk castration-sensitive prostate cancer.- Janssen.

Janssen Pharmaceutical announced that the FDA has approved a new indication for Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase III data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, Zytiga in combination with prednisone reduced the risk of death by 38 percent compared to placebos.

The study showed Zytiga in combination with prednisone reduced the risk of death by 38 percent compared to placebos (median OS not estimable vs. 34.7 months, respectively). Additional data demonstrated statistically significant delay in time to initiation of chemotherapy for patients in the Zytiga arm compared to those in the placebo arm (median time to initiation of chemotherapy not reached vs. 38.9 months, respectively). The most common adverse reactions (at least 10%) that occurred more commonly (more than 2%) in the Zytiga arm from an analysis of pooled safety data were fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough and headache.

Comment: On November 20, 2017, the European Commission granted approval to broaden the marketing authorization for Zytiga in combination with prednisone or prednisolone to include newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (HSPC).