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Xtandi (Enzalutamide) Gets Nod for Late-Stage Prostate Cancer
The FDA announced on August 31 that it has approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
Approved for prostate cancer patients previously treated with docetaxel, Xtandi was reviewed under the FDA’s priority review program. The drug received FDA approval 3 months ahead of the Prescription Drug User Fee goal date of November 22, 2012.
The safety and effectiveness of Xtandi were evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival in men receiving Xtandi compared with men receiving placebo.
The median overall survival period was 18.4 months in the Xtandi group compared with 13.6 months in the placebo group.
The most common side effects observed in patients taking Xtandi included weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory-tract infections, blood in the urine, tingling sensation, anxiety, and high blood pressure.
Seizures occurred in approximately 1% of those receiving Xtandi. Patients in the study who had a seizure stopped Xtandi therapy.
The drug will be co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill. and Medivation, Inc. of San Francisco, Calif.
For more information, visit the FDA Web site.