The U.S. Food and Drug Administration today 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, another anti-cancer treatment, Xtandi was reviewed under the FDA's priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the product's prescription drug user fee goal date of Nov. 22, 2012.
"The need for additional treatment options for advanced prostate cancer continues to be important for patients," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."
Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 241,740 men will be diagnosed with prostate cancer and 28,170 will die from the disease in 2012.
The safety and effectiveness of Xtandi was 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 (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.