FDA Grants Priority Review to sNDA for Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

On March 19, a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of enzalutamide to include men with nonmetastatic castration-resistant prostate cancer, based on data from the phase III PROSPER trial. Enzalutamide is currently indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

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 6 months of receipt, as compared to 10 months under standard review. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA to this sNDA is July 2018. In addition, the European Medicines Agency (EMA) has validated the Type II Variation submitted for enzalutamide seeking to expand the current indication to the same patient population, and started the review process on March 5.


The PROSPER trial evaluated enzalutamide plus androgen-deprivation therapy (ADT) vs ADT alone in 1,401 patients with nonmetastatic castration-resistant prostate cancer. The study met its primary endpoint, demonstrating that the use of enzalutamide plus ADT significantly reduced the risk of developing metastasis or death compared to ADT alone.

Adverse events in the PROSPER trial were higher in the enzalutamide plus ADT arm compared to ADT alone (87% vs. 77%), and were generally consistent with those reported in prior enzalutamide clinical trials in patients with metastatic castration-resistant prostate cancer. Results from the PROSPER trial were presented at the 2018 Genitourinary Cancers Symposium.

The FDA approved enzalutamide in 2012 for the treatment of patients with metastatic castration-resistant prostate cancer who had previously received docetaxel. In 2014, the FDA approved enzalutamide to treat patients with metastatic castration-resistant prostate cancer.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.