Pembrolizumab approved by FDA for cSCC


The U.S. Food and Drug Administration has approved pembrolizumab for cutaneous squamous cell carcinoma whose disease has shown to not be curable by radiation or surgery.

A new treatment for skin cancer will soon be on the market with the U.S. Food and Drug Administration (FDA) approval of pembrolizumab (Keytruda, Merck & Co.)

Available in 3 and 6-week dosing options, pembrolizumab is now approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that cannot be cured with radiation or surgery.

MORE: Potential first-line treatment for advanced cutaneous squamous cell carcinoma

The approval is supported by recently published data from a multicohort, open-label, multicenter trial (KEYNOTE-629) which evaluated the safety and efficacy of pembrolizumab 200 mg administered intravenously once every three weeks until unacceptable toxicity, progressive disease or a maximum of 24 months.

RELATED: Immunotherapy for advanced squamous cell carcinoma

Major efficacy outcome measures included objective response rate (ORR) and response duration evaluated by blinded independent central review consistent with RECIST 1.1 criteria, which were altered to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Results from the trial demonstrate an ORR of 34% (95% CI: 24, 44); however, a median response duration was not met (range, 2.7-13.1+ months).1

The prescribing information offers further direction on indications and dosing.


1. Center for Drug Evaluation and Research. (2020, June 24). FDA approves pembrolizumab for cutaneous squamous cell carcinoma. Retrieved June 24, 2020, from

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