Pembrolizumab approved by FDA for cSCC

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.

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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.

References:

1. Center for Drug Evaluation and Research. (2020, June 24). FDA approves pembrolizumab for cutaneous squamous cell carcinoma. Retrieved June 24, 2020, from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-cutaneous-squamous-cell-carcinoma