Core evidence clinical impact summary for enzalutamide

Outcome measure	Evidence	Implications
Disease-oriented evidence	Preclinical studies in castration-resistant prostate cancer cell lines and mouse xenograft models, including preclinical models harboring androgen receptor amplification.	Enzalutamide mediates its activity by potently antagonizing the androgen receptor, inhibits nuclear translocation of the androgen receptor, and impairs binding of the androgen receptor to promoter areas of androgen-regulated genes.
Patient-oriented evidence	Phase I/II clinical trial in men with chemotherapy-naïve and chemotherapy-pretreated metastatic castration-resistant prostate cancer (NCT00510718). Phase III randomized-controlled trial in men with chemotherapy-pretreated metastatic castration-resistant prostate cancer (NCT00974311).	Enzalutamide improved overall survival compared to placebo. Enzalutamide was also superior to placebo with respect to all secondary clinical endpoints, as well as quality-of-life endpoints. The safety profile of enzalutamide is favorable and common adverse events include fatigue, headache, and hot flashes; 1% of patients experienced seizure. Enzalutamide was approved by the US Food and Drug Administration on August 31, 2012 for men with docetaxel-pretreated metastatic castration-resistant prostate cancer.
Economic evidence	Pharmacoeconomic studies have not yet been conducted.	The current market price for enzalutamide is approximately $7000 per month.