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FDA expands Zytiga indication
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The FDA has expanded the approved use of abiraterone acetate in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer.
Abiraterone acetate (Zytiga, Janssen Biotech) is a pill that decreases testosterone production.
The FDA initially approved the drug in April 2011 for use by patients whose disease progressed after docetaxel treatment.
The FDA approved the expanded use based on results of a trial that involved patients with metastatic castration-resistant prostate cancer who had not received cytotoxic chemotherapy. Researchers randomly assigned patients to either prednisone plus abiraterone acetate (n=546) or prednisone plus placebo (n=542).
Researchers restricted entry to patients with metastases to the bone, soft tissue or lymph nodes. Patients who reported moderate to severe cancer pain, as well as those who had used opiates for cancer pain, were excluded from the study.
Researchers observed longer median OS among patients assigned to abiraterone acetate vs. placebo (35.1 months vs. 30.1 months; HR=0.79; 95% CI, 0.66-0.96). Median radiographic PFS was 8.3 months among patients assigned to the placebo arm but had not been reached for the study drug group (HR=0.43; 95% CI, 0.35-0.52).
The results were not statistically significant; however, researchers observed significant improvements in time to opiate use and time to cytotoxic chemotherapy.
Adverse events observed in patients assigned to abiraterone acetate included fatigue, joint swelling or discomfort, swelling caused by fluid retention, hot flush, diarrhea, vomiting, cough, high blood pressure, shortness of breath, urinary tract infection and bruising.