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# FDA Approves Expanded Xtandi Use
- URL: https://www.fdaweb.com/fda-approves-expanded-xtandi-use/
- Published: 2023-11-17T12:00:00.000Z
- Updated: 2026-09-14T14:16:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155823

FDA has approved Astellas Pharma’s Xtandi (enzalutamide) for an expanded use — treating non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

Approval was based on data from EMBARK (NCT02319837), a randomized, controlled clinical trial involving almost 1,100 patients with nmCSPC with high-risk BCR, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-non-metastatic-castration-sensitive-prostate-cancer-biochemical-recurrence?utm%5Fmedium=email&utm%5Fsource=govdelivery). “A statistically significant improvement in MFS \[metastasis-free survival \] was demonstrated for enzalutamide plus leuprolide compared with placebo plus leuprolide with a median that was not reached for either arm,” it says.

The most common adverse reactions were hot flush, musculoskeletal pain, fatigue, fall, and hemorrhage, the agency says.