BRIEF — New FDA nod for Zytiga

The US Food and Drug Administration (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% compared to placebos.

Zytiga, from US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen unit, had already been approved for use in combination with prednisone for treatment of metastatic castration-resistant prostate cancer.