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Astellas, Medivation cancer drug wins FDA approval

9/4/2012

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.



The FDA announced the approval of Xtandi (enzalutamide) for castration-resistant prostate cancer that has spread or recurred despite medical or surgical therapy to minimize testosterone.



"The need for additional treatment options for advanced prostate cancer continues to be important for patients," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a person's life."



About 241,740 men will be diagnosed with prostate cancer, and 28,170 will die from it this year, according to the National Cancer Institute, part of the National Institutes of Health.




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