FDA grants accelerated review for expanded use of Xtandi

Astellas Pharma (OTCPK:ALPMF) and collaboration partner Pfizer (PFE +1%) announce that the FDA has granted Priority Review status for the latter’s supplemental marketing application for Xtandi (enzalutamide) for the treatment of metastatic hormone-sensitive prostate cancer.

The agency’s action date is in Q4.

Xtandi was first approved in the U.S. in August 2012 for metastatic castration-resistant prostate cancer and in July 2018 for non-metastatic castration-resistant prostate cancer.

https://seekingalpha.com/news/3493749-fda-grants-accelerated-review-expanded-use-xtandi