Medication Monitor

Generic Name (Trade Name—Company)
March 1, 2018

Abiraterone acetate

(Zytiga—Janssen Biotech)
Agent plus prednisone approved for treatment of earlier form of metastatic prostate cancer

FDA approved a new indication for abiraterone acetate in combination with prednisone for the treatment of patients with metastatic, high-risk castration-sensitive prostate cancer (CSPC).

Approval was based on Phase III data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic, high-risk CSPC, abiraterone acetate in combination with prednisone reduced the risk of death by 38% compared with placebos.

The most common adverse reactions (≥10%) from pooled safety data were fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache.

On November 20, 2017, the European Commission granted approval to broaden the marketing authorization for abiraterone acetate in combination with prednisone or prednisolone to include newly diagnosed, high-risk, metastatic hormone-sensitive prostate cancer (HSPC). Similar submissions have been made in Japan, Canada, Mexico, Switzerland, Singapore, and the Philippines, and approved in Brazil and Taiwan. If approved, these submissions will broaden use of abiraterone acetate in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.