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# Merck’s Keytruda OK’d for Cell Carcinoma
- URL: https://www.fdaweb.com/mercks-keytruda-okd-for-cell-carcinoma/
- Published: 2020-06-25T12:00:00.000Z
- Updated: 2026-09-14T16:19:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147102

FDA has approved Merck’s Keytruda (pembrolizumab) as monotherapy for treating patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Approval was based on data from the Phase 2 KEYNOTE-629 trial that demonstrated Keytruda’s meaningful efficacy and durability of response, with an objective response rate of 34%, a complete response rate of 4% and a partial response rate of 31%, according to the company. Among responding patients, 69% had ongoing responses of six months or longer, it says.

Merck says that adverse reactions occurring in patients with cSCC were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with Keytruda as a single agent. Laboratory abnormalities that occurred at a higher incidence included lymphopenia (11%), it says.