The FDA approved pembrolizumab (Keytruda, Merck) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The approval was based on the results of the multicenter, multicohort, nonrandomized, open-label, phase 2 KEYNOTE-629 trial (ClinicalTrials.gov Identifier: NCT03284424). In the trial, 105 patients received 200 mg of pembrolizumab every three weeks until disease progression or unacceptable toxicity, for a