The Skin Cancer Foundation Comments on FDA Approval of Libtayo (Cemiplimab- RWLC), for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

Cemiplimab is the first and only treatment specifically approved and available for advanced CSCC in the U.S.

New York, NY (October 1, 2018) – On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) and for patients with advanced local CSCC who are not suitable candidates for surgery or radiation. Cutaneous squamous cell carcinoma is a type of nonmelanoma skin cancer arising from the squamous cells in the epidermis, the skin’s outermost layer.

While fewer people develop CSCC than basal cell carcinoma (BCC), the most common type of skin cancer, CSCC can be more dangerous. CSCC has a higher risk than BCC of becoming locally advanced or metastatic. Studies have shown that about 1.5 percent of patients with CSCC die of the disease — approximately 15,000 people in the U.S. each year. Approximately 1.8 million people in the U.S. develop CSCC each year.

Cemiplimab is an immuno-oncology drug, administered intravenously, that harnesses the power of the body’s own immune system to fight cancer. It works by targeting PD-1, a protein present on immune cells that normally keeps the immune system in check. Tumors that express PD-1 bind to T cells, switching off the cell’s ability to attack the tumor. Left unchecked, this allows the tumor to thrive. Cemiplimab blocks PD-1, turning back on the T cells’ ability to attack tumors. FDA approval of cemiplimab was based on data from a phase 2 clinical trial, where 46 percent of patients responded to the drug and a previous phase 1 trial with a combined 47 percent of patients responding to the drug.

An estimated 95 percent of CSCCs are detected when they’re early stage or localized, which means they are typically limited to the skin or the tissue just below. An estimated 50,000 people in the U.S. each year learn they have CSCC that has advanced to the point that it may be very challenging to treat.

“The therapies that physicians traditionally offer patients with advanced cutaneous squamous cell carcinoma have been limited, so the approval of cemiplimab is an important tool in the CSCC treatment tool box,” says Deborah S. Sarnoff, MD, president of The Skin Cancer Foundation. “Patients and caregivers often contact our organization and share stories of CSCC that cannot be surgically removed or that fail to respond to radiation or chemotherapy. Over the past few years immunotherapies have significantly improved outcomes for people with advanced melanoma, and we’re hopeful that cemiplimab will make a similar difference for people with advanced CSCC.”

Cemiplimab was jointly developed by Sanofi and Regeneron under a global collaboration agreement. Regeneron and Sanofi are financial supporters of The Skin Cancer Foundation.

For more information about cutaneous squamous cell carcinoma, visit


About The Skin Cancer Foundation
The Skin Cancer Foundation is the only global organization solely devoted to the prevention, early detection and treatment of skin cancer. The mission of the Foundation is to decrease the incidence of skin cancer through public and professional education and research. Since its inception in 1979, the Foundation has recommended following a complete sun protection regimen that includes seeking shade and covering up with clothing, including a wide-brimmed hat and UV-blocking sunglasses, in addition to daily sunscreen use. For more information, visit

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