The Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc; Sanofi and Regeneron), a programmed death receptor-1 (PD-1) blocking antibody, for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This marks the first FDA approval of a drug specifically indicated for advanced CSCC.

The approval was based on data from 2 open-label, non-randomized studies where patients with metastatic (nodal or distant) CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation received Libtayo 3mg/kg intravenously every 2 weeks for up to 48 weeks (Study 1423) or up to 96 weeks (Study 1540) until disease progression, unacceptable toxicity, or completion of planned treatment. The primary efficacy outcome measures were confirmed objective response rate (ORR; percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment), as assessed by independent central review (ICR) and ICR-assessed duration of response.

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Results showed that the confirmed ORR was 47.2% in the combined CSCC group (N=108; 75 with metastatic disease and 33 with locally-advanced disease); 61% of these patients (N=31) had a duration of response ≥6 months. The most common adverse reactions associated with therapy included fatigue, rash, and diarrhea.

“With the Libtayo approval, the FDA has approved 6 immune checkpoint inhibitors targeting the PD-1 / PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced CSCC,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients.”

Libtayo will be supplied as a 350mg/7mL (50mg/mL) solution in a single-dose vial.

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