publication date: Feb. 9, 2018

Drugs and Targets FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

FDA approved abiraterone acetate (Zytiga)  tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). The drug is sponsored by Janssen Biotech Inc.

FDA initially approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC) who had received prior chemotherapy, and expanded the indication in 2012 for patients with metastatic CRPC.  

The latest approval was based on LATITUDE (NCT01715285), a placebo controlled international clinical trial that randomized 1,199 patients with metastatic high-risk CSPC. Patients received either abiraterone acetate, 1,000 mg orally once daily with prednisone 5 mg once daily (n=597), or placebos orally once daily (n=602). Patients in both arms received a gonadotropin releasing hormone or had a bilateral orchiectomy. The major efficacy endpoint was overall survival (OS). Median OS was not estimable and 34.7 months in the abiraterone acetate and placebos arms, respectively (HR 0.621; 95% CI: 0.509, 0.756; p<0.0001). The median time-to-initiation of chemotherapy was not reached for patients on abiraterone acetate with prednisone and 38.9 months for those receiving placebos (HR 0.44; 95% CI: 0.35, 0.56; p<0.0001).

The most common adverse reactions in at least 5% of patients receiving abiraterone acetate on LATITUDE were hypertension, hot flush, hypokalemia, increased alanine aminotransferase or aspartate aminotransferase, headache, urinary tract infection, upper respiratory … Continue reading FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

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