Advanced prostate cancer drug receives FDA approval

May 12, 2011

The FDA has approved abiraterone acetate (ZYTIGA), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere).

The FDA has approved abiraterone acetate (ZYTIGA), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere).

"In a phase III study, treatment with ZYTIGA plus prednisone showed a significant increase in median survival compared with placebo plus prednisone," said co-investigator Johann S. de Bono, MD, PhD, of the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London. "It’s an exciting time for men with prostate cancer, and I believe that abiraterone acetate will play an essential role in clinical practice."

Results of the randomized, placebo-controlled, multicenter study showed that at pre-specified interim analysis, treatment with abiraterone, in combination with prednisone, resulted in a 35% reduction in the risk of death (14.8 months vs. 10.9 months [hazard ratio=0.646; 95% CI: 0.543, 0.768; p

The most common adverse reactions (≥5%) reported in the clinical study were: joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, and upper respiratory tract infection.

"This FDA approval represents a welcome new option in the treatment of metastatic prostate cancer," said co-investigator Howard Scher, MD, of Memorial Sloan-Kettering Cancer Center, New York. "As a clinician, I believe the efficacy and safety profile of abiraterone acetate, as well as its oral, once-daily formulation, will help address the important need for additional therapeutic choices for men living with this serious disease."

In a statement, the Prostate Cancer Foundation, which provided financial support for abiraterone research, called the drug’s approval "a great day for prostate cancer patients seeking life-prolonging therapy for advanced disease."