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# FDA Approves Updated Label for Xtandi in Prostate Cancer
- URL: https://www.fdaweb.com/fda-approves-updated-label-for-xtandi-in-prostate-cancer/
- Published: 2016-10-21T12:00:00.000Z
- Updated: 2026-09-14T21:41:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137140

FDA has approved an Astellas Pharma and Pfizer supplemental NDA to change product labeling for Xtandi (enzalutamide) 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, according to the companies.

“The updated label includes data that enzalutamide reduces the risk of radiographic progression or death by 40% 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 companies say. The safety profile of enzalutamide was consistent with results of earlier enzalutamide trials, they add.