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# FDA Accelerated Approval for Merck’s Keytruda in Head/Neck Cancer
- URL: https://www.fdaweb.com/fda-accelerated-approval-for-mercks-keytruda-in-head-neck-cancer/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136432

FDA has granted Merck accelerated approval for Keytruda (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The approval was based on tumor response rate and durability of response data, according to the company. In Merck’s KEYNOTE-012 study, an objective response rate of 16% and a complete response rate of 5% were shown in Keytruda-treated patients, with responses of six months or longer observed in 82% of the responding patients, it says. Keytruda was previously approved for treating patients with unresectable or metastatic melanoma, and patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test.