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# Priority Review for Keytruda in Hepatocellular Carcinoma Patients
- URL: https://www.fdaweb.com/priority-review-for-keytruda-in-hepatocellular-carcinoma-patients/
- Published: 2018-07-11T12:00:00.000Z
- Updated: 2026-09-15T00:18:32.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141848

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating previously treated patients with advanced hepatocellular carcinoma. The submission is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology Annual Meeting and published simultaneously in *The Lancet Oncology.* The agency has set a user fee review target action date of 11/9\. Keytruda has been approved for 10 other indications, including melanoma, lung cancer, head and neck cancer and Hodgkin lymphoma.