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# Astellas/Pfizer sNDA for Xtandi Gains Priority Review
- URL: https://www.fdaweb.com/astellas-pfizer-snda-for-xtandi-gains-priority-review/
- Published: 2019-08-21T12:00:00.000Z
- Updated: 2026-09-15T01:45:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144822

FDA has granted Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) that is seeking an indication for treating men with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is currently indicated for treating patients with castration-resistant prostate cancer.

The submission is based on data from the Phase 3 ARCHES trial that evaluated the efficacy and safety of Xtandi plus androgen deprivation therapy (ADT) versus ADT plus placebo in men with mHSPC. The primary endpoint of radiographic progression-free survival was met in the study, according to the companies. Additionally, the submission is supported by data from ENZAMET, an Astellas-supported Phase study that evaluated Xtandi plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with mHSPC to provide an active control. The primary endpoint of overall survival was met in the ENZAMET trial, they say.

The companies expect a fourth quarter review action target date.