19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer.

Pfizer and Astellas announced today that a supplemental new drug application for Xtandi (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. FDA. If approved, the application would expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer (CRPC), based on data from the Phase 3 PROSPER trial. Xtandi is currently indicated for the treatment of patients with metastatic CRPC.

The FDA grants priority review designation to applications for drugs that, if approved, may offer significant improvements in the safety and effectiveness of the treatment of serious conditions when compared to standard applications. Under priority review, the FDA aims to take action on an application within six months of receipt, as compared to ten months under standard review. The Prescription Drug User Fee Act goal date assigned by the FDA is July 2018. In addition, the EMA has validated the Type II Variation submitted for Xtandi seeking to expand the current indication to the same patient population and started the review process on March 5.

Read Pfizer press release