FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma

On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced cutaneous SCC. Cemiplimab targets the programmed cell death protein 1 (PD-1) pathway.

“We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the cemiplimab approval, the FDA has approved six immune checkpoint inhibitors targeting the the PD-1/programmed cell death ligand 1 (PD-L1) pathway for treating a variety of tumors…,” 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.”

Cutaneous SCC is the second most common human cancer in the United States, with an estimated annual incidence of approximately 700,000 cases. The most common form of skin cancer is basal cell cancer. Cutaneous SCC usually develops in skin areas that have been regularly exposed to the sun or other forms of ultraviolet radiation. Although the majority of patients with cutaneous SCC are cured with surgical resection, a small percentage of patients will develop advanced disease that no longer responds to local treatments including surgery and radiation. Advanced cutaneous SCC may cause disfigurement at the site of the tumor and local complications such as bleeding or infection, or it may metastasize to local lymph nodes, distant tissues, and organs.

Study Findings

The safety and efficacy of cemiplimab was studied in two open-label clinical trials. A total of 108 patients (75 with metastatic disease and 33 with locally advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate.

Results showed that 47.2% of all patients treated with cemiplimab responded to the treatment. The majority of these patients had ongoing responses at the time of data analysis.

Common side effects of cemiplimab include fatigue, rash, and diarrhea. Cemiplimab must be dispensed with a patient Medication Guide that describes uses of the drug and its serious warnings, included immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic problems, and kidney problems. Patients should also be monitored for infusion-related reactions.  

The FDA granted this application Breakthrough Therapy and Priority Review designations.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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