Abiraterone Before Chemo Improves Survival: Label Update Roxanne Nelson, RN April 01, 2015 The US Food and Drug Administration (FDA) has approved a label update for abiraterone acetate (Zytiga, Janssen Pharmaceuticals, Inc.), which now states that the drug significantly improves survival as compared with placebo when given before chemotherapy to men with metastatic castration-resistant prostate cancer (MCRPC). Abiraterone had already been approved by the FDA for this indication, but the new label specifically mentions the survival benefit. The clinical data showing that benefit have recently been published. Abiraterone first received FDA approval in April 2011 as a second-line treatment following docetaxel chemotherapy for patients with MCRPC. In December 2012, that indication was expanded to include use in the first-line setting on the basis of an interim analysis of a randomized phase 3 trial that showed that progression-free survival was significantly longer in the abiraterone group than in the placebo group. The label update is based on the final analysis of that study, known as COU-AA-302, which has now been published in the Lancet Oncology. At the time of the interim analysis, median overall survival had not yet been reached in the abiraterone group; it was 27.2 months in the placebo group. The mortality rate was lower in the abiraterone group, however, than in the placebo group (27% vs 34%), with a 25% decrease in the risk for death (hazard ratio [HR], 0.75; P = .01), "indicating a strong trend toward improved survival," the study authors said at that time. Now in the final analysis of the double-blind, placebo-controlled COU-AA-302 study, abiraterone plus prednisone significantly prolonged median overall survival compared with placebo plus prednisone in this population of chemotherapy-naive men with MCRPC. After a median follow-up period of 49.2 months, men in the abiraterone group had a median overall survival of 34.7 months, as compared with 30.3 months in the placebo plus prednisone arm (HR = 0.81; 95% confidence interval [CI], 0.70 - 0.93; P = .0033). "The statistically significant improvement in overall survival demonstrated in the final analysis and resulting label update help affirm the established efficacy, safety, and tolerability that physicians treating men with metastatic castration-resistant prostate cancer have seen with abiraterone," principal investigator Charles Ryan, MD, professor of clinical medicine and urology at the University of California, San Francisco, said in a statement. "Representing a median follow-up of 4 years, this analysis adds to the robust body of clinical data supporting abiraterone as an important treatment option for men with metastatic castration-resistant prostate cancer."
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