The FDA has approved cemiplimab-rwlc (Libtayo) 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 is the first treatment approved by the FDA specifically for advanced CSCC.
Cemiplimab-rwlc is administered as an intravenous injection and works by blocking the programmed death cell protein 1 pathway.
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Approval was based on 2 open label clinical trials that included a total of 108 participants. Overall, 47.2% of participants treated with cemiplimab-rwlc had tumors that shrank or disappeared. The majority of participants continued to respond to treatment at the time of data analysis.
Common adverse effects associated with treatment included fatigue, rash, and diarrhea. In addition, cemiplimab-rwlc can cause immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and kidney problems. Patients who receive this therapy should be monitored for infusion-related reactions and given a Medication Guide that describes the uses and serious warnings associated with cemiplimab-rwlc.