FDA approves Sanofi and Regeneron's Libtayo

USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN) scored a hit on Friday, when the US Food and Drug Administration approved their first immuno-oncology drug as a skin cancer treatment.

The FDA approved Libtayo (cemiplimab) 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.

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and available for advanced CSCC in the USA.