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# FDA Priority Review for Merck Keytruda sBLA
- URL: https://www.fdaweb.com/fda-priority-review-for-merck-keytruda-sbla/
- Published: 2019-02-11T12:00:00.000Z
- Updated: 2026-09-15T01:02:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143342

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The submission is based in part on data from the pivotal Phase 3 KEYNOTE-048 trial where the therapy showed a significant improvement in overall survival compared with the standard of care.

Merck says KEYNOTE-048 also serves as the confirmatory trial for KEYNOTE-012, a Phase 1b study which supported the previous accelerated approval for Keytruda as monotherapy for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Keytruda is an anti-PD-1 therapy that Merck says works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The humanized monoclonal antibody blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, “thereby activating T lymphocytes which may affect both tumor cells and healthy cells,” it says.