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FDA Approves Enzalutamide for Nonmetastatic CRPC

Jason M. Broderick @jasoncology
Published: Friday, Jul 13, 2018

The FDA has approved enzalutamide (Xtandi) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent.

The FDA initially approved enzalutamide in 2012 as a treatment for men with metastatic CRPC following docetaxel. This approval was expanded in 2014 to include treatment with the antiandrogen agent prior to chemotherapy.
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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