Posted by Michael Wonder on 15 Jul 2018
U.S. FDA approves Xtandi (enzalutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer
13 July 2018 - First and only oral treatment FDA approved for both non-metastatic and metastatic castration-resistant prostate cancer.
Astellas and Pfizer today announced the U.S. FDA approved a supplemental new drug application 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 castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes Xtandi the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.
Xtandi was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.
