FDA Approves Libtayo as First and Only Treatment for Advanced CSCC

By Marie Rosenthal

The FDA approved cemiplimab-rwlc (Libtayo, Regeneron/Sanofi) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 

Cemiplimab-rwlc is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 (programmed cell death protein-1), which is found on the body’s immune cells and some cancer cells. It works by blocking this pathway,