Xtandi Label Updated to Include New Drug Comparison Data
The prescribing information for Xtandi (enzalutamide capsules; Astellas and Pfizer) has been updated to include new clinical data versus bicalutamide from the TERRAIN study.
The TERRAIN study enrolled 375 chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). The trial was designed to evaluate patients who were randomized 1:1 to receive enzalutamide 160mg once daily versus bicalutamide 50mg taken once daily.
The updated labeling includes data that enzalutamide reduces the risk of radiographic progression or death by 40% compared with bicalutamide, showing a median radiographic progression-free survival (rPFS) of 19.5 months for the enzalutamide group versus a median of 13.4 months for the bicalutamide group (hazard ratio = 0.60 [0.43, 0.83]; 95% confidence interval) based on an analysis recommended by the FDA.
Enzalutamide is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. Xtandi is FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
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