FDA Approves Cemiplimab for Metastatic Cutaneous Squamous Cell Carcinoma
Posted: Monday, October 1, 2018
On September 28, 2018, the U.S. Food and Drug Administration approved cemiplimab-rwlc (Libtayo), a PD-1 inhibitor, for intravenous use in the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for the treatment of advanced cutaneous squamous cell carcinoma.
The safety and efficacy of cemiplimab were 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 results showed that 47.2% of all patients treated with cemiplimab experienced tumor shrinkage or disappearance. The majority of these patients had ongoing responses at the time of data analysis.
Common side effects associated with cemiplimab include fatigue, rash, and diarrhea. Severe or life-threatening reactions include the risk of immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and kidney problems. Patients treated with cemiplimab should also be monitored for infusion-related reactions.
