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).
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