The FDA granted priority review to Astellas and Pfizer’s Xtandi (enzalutamide) for treatment of men with metastatic hormone-sensitive prostate cancer.
The submission was based on the results two phase 3 clinical trials that evaluated the drug’s efficacy and safety with and without androgen deprivation therapy. The studies met their primary endpoints.
Xtandi is an androgen receptor inhibitor that was previously approved to treat patients with castration-resistant prostate cancer last year. The FDA is expected to make a decision on the new indication this year.