FDA grants priority review to Pfizer and Astellas’ sNDA for XTANDI

By PBR Staff Writer

The US Food and Drug Administration (FDA) has accepted and granted priority review to Pfizer and Astellas Pharma’s supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) to treat non-metastatic castration-sensitive prostate cancer (nmCSPC) patients with high-risk biochemical recurrence (BCR).