FDA approves expanded indication for Keytruda in cSCC

6 July 2021

The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) anti-PD-1 therapy, as monotherapy for the treatment of locally-advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

This approval is based on data from the second interim analysis of the Phase II KEYNOTE-629 trial, in which Keytruda demonstrated an objective response rate (ORR) of 50%, including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.

Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer.

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