U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) - First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC -
(WorldNews Japan)

TOKYO and NEW YORK, July 13, 2018 -Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., `Astellas`) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with...