FDA approves first treatment for advanced form of the second most common skin cancer

FDA has approved cemiplimab-rwlc (Libtayo—Regeneron Pharmaceuticals) injection for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA has approved cemiplimab-rwlc (Libtayo—Regeneron Pharmaceuticals) injection for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC. The drug targets the PD-1 cellular pathway. "We're continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six 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 FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. With an estimated incidence of about 700,000 cases per year, CSCC is the second most common human cancer in the United States, after basal cell cancer. Results of two open-label clinical trials involving 108 patients found that 47.2% of all patients treated with cemiplimab-rwlc had partial shrinkage or complete disappearance of their tumor(s) after treatment. Common adverse effects of the treatment include fatigue, rash, and diarrhea. Cemiplimab-rwlc must be dispensed with a patient Medication Guide that details uses of the drug and its serious warnings. The drug can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they function, with sometimes severe or life-threatening reactions that can lead to death.