FDA approves Libtayo® as first treatment for advanced cutaneous squamous cell carcinoma

The US Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc), the first treatment in the world for patients with metastatic cutaneous squamous cell (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 U.S.

The recommended dosage is 350 mg administered as an intravenous infusion over 30 minutes every three weeks, until disease progression or unacceptable toxicity.  Libtayo is available as a single-dose 350 mg vial.

Libtayo will be jointly brought to market in the US by Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron.