FDA approves sNDA for XTANDI® (enzalutamide) capsules in advanced prostate cancer
Astellas Pharma and Pfizer announced the FDA approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI® (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in rPFS. October 21, 2016