U.S. Food and Drug Administration (FDA) has approved Xtandi (enzalutamide) for the treatment of late stage prostate cancer. This drug has been approved under the FDA’s priority review program and has been approved “three months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012”.
Prostate cancer is the cancer of the prostate gland in the male reproductive system. This cancer has been diagnosed in about 80% of men approaching the age of 80. It has been estimated by National Cancer Institute that in 2012, nearly 241,740 men will be diagnosed with prostate cancer and 28,170 would die from the disease.
“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.”
Xtandi (enzalutamide) has been approved for the patients who were previously treated with docetaxel, one of the anti-cancer drugs. Researchers have found that the median overall survival for the patients receiving this drug was 18.4 months as compared to 13.6 months. Among the most common side effects were “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 infections, blood in urine, tingling sensation, anxiety, and high blood pressure” as reported by FDA.