U.S. Food and Drug Administration approval of Zytiga (abiraterone acetate) has been expanded to include treating late-stage castration-resistant prostate cancer before the administration of chemotherapy, the agency said Monday.
The drug, designed to decrease production of the male sex hormone testosterone, was first approved in November 2011. Testosterone is thought to spur the growth of prostate tumors, the FDA said in a news release.
Zytiga’s approval for the new use followed a clinical study of 1,088 men with advanced, castration-resistant prostate cancer who hadn’t received chemotherapy. Men who took Zytiga had a median survival of 35.3 months, compared to 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.
Zytiga is marketed by Janssen Biotech, based in Horsham, Penn.