BRIEF—FDA approves Xtandi for CRPC

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide), from Japan’s Astellas Pharma and US pharma giant Pfizer, following FDA Priority Review designation based on results from the Phase III 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.

"With today’s approval, there is now a new option for men with non-metastatic CRPC, who are in between the failure of androgen deprivation therapy resulting in CRPC and the onset of metastatic disease,” said Jonathan Simons, Prostate Cancer Foundation president and chief executive.

“As a foundation that drives research aimed at improving patient outcomes, it is exciting to see approvals like this, which are vital to help address unmet patient needs.” Dr Simons added.