The US Food and Drug Administration (FDA) has approved abiraterone acetate (Zytiga) tablets in combination with prednisone for the treatment of metastatic prostate cancer patients with high-risk castration-sensitive disease, according to a press release from the agency.
The approval was based on results of LATITUDE, a phase III placebo-controlled international trial.
“LATITUDE was a large global trial which produced impressive and clinically significant results in overall survival,” said principal investigator Karim Fizazi, MD, PhD, of the Institut Gustave Roussy in Villejuif, France, in a press release. “With today’s approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer.”
The trial randomized 1,199 prostate cancer patients with metastatic high-risk castration-sensitive disease to either 1,000-mg oral abiraterone acetate plus 5-mg prednisone (n = 597) or placebo (n = 602). Patients in both arms also received a gonadotropin-releasing hormone analog or had a bilateral orchiectomy.
At 30.4 months of median follow-up, overall survival—the primary endpoint—was not estimable in patients who were treated with abiraterone acetate compared with 34.7 months in those who received placebo (hazard ratio [HR], 0.621; 95% CI, 0.509–0.756; P < .0001). The median time-to-initiation of chemotherapy was also not reached in the abiraterone acetate arm compared with 38.9 months in the placebo arm (HR, 0.44; 95% CI, 0.35–0.56; P < .0001).
The most common adverse events (≥ 10%) that occurred more commonly (> 2%) in patients receiving abiraterone acetate were arthralgia, cough, diarrhea, edema, fatigue, headache, hot flush, hypertension, hypokalemia, nausea, upper respiratory infection, and vomiting.
The combination of abiraterone acetate plus prednisone was first approved by the FDA in 2011 for patients with metastatic castration-resistant prostate cancer who had previously been treated with chemotherapy. The indication was then expanded in 2012 for the first-line treatment of patients with metastatic castration-resistant prostate cancer.