A supplemental New Drug Application (sNDA) has been approved to update the U.S. product labeling for enzalutamide (Xtandi) capsules to include new clinical data versus bicalutamide from the TERRAIN study.
The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.
The TERRAIN study evaluated men with metastatic CRPC. The updated label includes data that enzalutamide reduces the risk of radiographic progression or death by 40 percent compared with bicalutamide, showing a median 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. The safety profile of enzalutamide was consistent with results of earlier enzalutamide trials.