Designation for Advanced Cutaneous Squamous Cell Carcinoma

Breakthrough Designation for Advanced Cutaneous Squamous Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has approved cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1.

The approval was based on results for cemiplimab from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients were previously reported at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2017.

CSCC is the second most common type of skin cancer in the United States. Although CSCC has a good prognosis when caught early, it can prove especially difficult to treat when it progresses to advanced stages. Patients at this stage can be disfigured due to multiple surgeries to remove CSCC tumors on the head, neck and other parts of the body. CSCC is responsible for the most deaths among non-melanoma skin cancer patients.


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