The FDA has expanded the indication for abiraterone acetate to include treating late-stage castration-resistant prostate cancer before the administration of chemotherapy, the agency said today.
The drug, designed to decrease production of testosterone, was first approved in November 2011 for use in patients whose prostate cancer progressed after treatment with docetaxel.
FDA’s expanded indication followed a clinical study of 1,088 men with advanced, castration-resistant prostate cancer who had not received chemotherapy. Men who received the drug had a median survival of 35.3 months compared with 30.1 months among those who took a placebo.
The most common adverse reactions included fatigue, swollen joints, hot flushes, diarrhea, vomiting, cough, and high blood pressure.