FDA approves Xtandi(Astellas/Medivation)to treat castration- resistant Prostate Cancer - 01-Sep-2012

The FDA has on 31 August 2012 approved Xtandi (enzalutamide) from Astellas/Medivation 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 22 November. 2012.