On February 7, 2018, the FDA approved Zytiga (abiraterone acetate; from Janssen Biotech) for use, in combination with prednisone, in patients with metastatic, high-risk, castration-sensitive prostate cancer.
The combination of Zytiga plus prednisone was previously approved for patients with metastatic, castration-resistant prostate cancer who had received chemotherapy, or for patients with newly diagnosed metastatic castration-resistant prostate cancer.
In the clinical trial that led to this approval, the exact duration of survival with Zytiga plus prednisone could not be determined yet (as a result of only a few deaths) compared with an average survival period of 34.7 months with placebo.
The most common side effects with Zytiga are hypertension, hot flush, hypokalemia, headache, urinary tract infection, upper respiratory tract infection, and cough.
