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# Merck’s Keytruda Approved for Esophageal Carcinoma
- URL: https://www.fdaweb.com/mercks-keytruda-approved-for-esophageal-carcinoma/
- Published: 2021-03-23T12:00:00.000Z
- Updated: 2026-09-14T16:51:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148941

FDA has approved Merck’s Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. The approval was based on data from the KEYNOTE 590 (NCT03189719) trial, which demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-esophageal-or-gej-carcinoma?ref=fdaweb.com). Median OS was 12.4 months for the pembrolizumab arm versus 9.8 months for the chemotherapy arm, and median PFS was 6.3 and 5.8 months, respectively.