The FDA’s approval of enzalutamide (XTANDI) to treat metastatic castration-resistant prostate cancer (CRPC) in the pre-chemotherapy setting is a potential game changer for both patients and treating physicians, especially urologists, according to one leader in the prostate cancer field.
The therapeutic options for this patient population will likely extend beyond enzalutamide, another pointed out.
Enzalutamide, an oral, once-daily androgen receptor inhibitor, was originally approved in 2012 for use in patients with metastatic CRPC who previously received docetaxel (Taxotere). The new indication approves enzalutamide for use in men with metastatic CRPC who have not received chemotherapy.
The most recent approval follows a priority review of the supplemental new drug application that was based on results of the phase III PREVAIL trial. In that study, men receiving enzalutamide and gonadotropin-releasing hormone (GnRH) therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.
Enzalutamide significantly reduced the risk of death by 29% compared with placebo (HR: 0.71; p<.0001) and significantly reduced the risk of radiographic progression or death by 83% compared with placebo (HR: 0.17; p<.0001). When compared to placebo, treatment with enzalutamide also delayed time to initiation of chemotherapy and time to a skeletal-related event.
“In 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,” said PREVAIL co-principal investigator Tomasz M. Beer, MD, of Oregon Health & Science University, Portland.
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