The Food and Drug Administration has approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).
The FDA first approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer who had received prior chemotherapy. The indication was expanded in 2012 to patients with metastatic castration-resistant prostate cancer, the FDA said in a.
The most common adverse reactions in LATITUDE for patients in the abiraterone acetate arm included hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory tract infection, and cough.
The recommended dose for abiraterone acetate for metastatic CSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving the drug should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy, the FDA said.
Abiraterone acetate is marketed as Zytiga by Janssen Biotech.