Pre-Chemo Enzalutamide Approved for Metastatic Castration-Resistant Prostate Cancer

The FDA has expanded the approval for enzalutamide (Xtandi) to include the treatment of men with chemotherapy-naive metastatic castration-resistant prostate cancer.

The FDA has expanded the approval for enzalutamide (Xtandi) to include the treatment of men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), based on survival data from the phase III PREVAIL trial.

In the study, treatment with enzalutamide improved overall survival (OS) by 29% and radiographic progression-free survival (rPFS) by 81% compared with placebo. The expanded indication for the androgen receptor inhibitor was granted under the FDA's priority review program. Enzalutamide was initially approved for chemotherapy-pretreated men with mCRPC in August 2012.

"[E]nzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer," co-principal investigator Tomasz M. Beer, MD, the deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University, said in a press release. "[I]n the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy."

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