News >

FDA Grants Enzalutamide Priority Review for Nonmetastatic CRPC

Jason Harris
Published: Monday, Mar 19, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The FDA has granted a priority review to a supplemental new drug application (sNDA) for enzalutamide (Xtandi) for the treatment of men with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the companies developing the antiandrogen agent.

The FDA initially approved enzalutamide as a treatment for men with metastatic CRPC following docetaxel in 2012. This approval was expanded to include treatment with the antiandrogen prior to chemotherapy in 2014.
Hussain M, Fizazi K, Saad F, et al. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). J Clin Oncol. 2018;36 (suppl 6S; abstr 3).

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 2nd Annual International Congress on Oncology Pathology™Aug 31, 20191.5
Publication Bottom Border
Border Publication
x