The FDA announced approval of cemiplimab-rwlc for basal cell carcinoma (BCC), giving dermatologists managing locally advanced and metastatic BCC now have another option in their toolbox.
Cemiplimab is the first immunotherapy treatment for advanced BCC, specifically for patients who have previously failed treatment with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is not appropriate. It has been fully approved for locally advanced BCC and received accelerated approval for metastatic BCC based on an interim analysis on the therapy’s impact on tumor response rate and durability of response. Continued approval is contingent on additional data from ongoing trials verifying clinical benefit.
In an open-label, multicenter, phase 2 trial, patients who were received cemiplimab 350 mg every 3 weeks were found to have clinically meaningful and durable responses to treatment.
The approval is the second indication for cemiplimab; it was approved in 2019 for locally advanced or metastatic squamous cell carcinoma.
FDA approves Libtayo® (cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma. News release. Regeneron Pharmaceuticals, Inc; February 9, 2021. Accessed February 10, 2021. https://www.prnewswire.com/news-releases/fda-approves-libtayo-cemiplimab-rwlc-as-first-immunotherapy-indicated-for-patients-with-advanced-basal-cell-carcinoma-301225400.html