The FDA approved the use of enzalutamide (Xtandi, Astellas) for patients with nonmetastatic castration-resistant prostate cancer (CRPC), based on results from the phase 3 PROSPER trial.
The approval of the supplemental New Drug Application broadens the indication for enzalutamide to include both nonmetastatic and metastatic CRPC.
“With today’s approval, there is now a new option for men with nonmetastatic CRPC who are in between the failure of androgen deprivation therapy [ADT]