FDA approves abiraterone acetate for metastatic high-risk CSPC


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 press statement.

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The current approval was based on a boost in overall survival (OS) with abiraterone acetate demonstrated in the phase 3 LATITUDE trial. After a median follow-up of 30.4 months, median OS was 34.7 months in the placebo arm versus not yet reached in the abiraterone acetate arm (hazard ratio, 0.621; 95% confidence interval, 0.509-0.756; P less than .0001). The trial randomized 1,199 patients with metastatic high-risk CSPC to either abiraterone acetate, 1,000 mg orally once daily with prednisone 5 mg once daily (n = 597), or placebo orally once daily (n = 602). Patients in both arms received a gonadotropin-releasing hormone or had a bilateral orchiectomy. The median time to initiation of chemotherapy was not reached for patients receiving abiraterone acetate with prednisone and 38.9 months for those receiving placebo (HR, 0.44; 95% CI, 0.35-0.56; P less than .0001), according to the press statement.

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.

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