Regeneron’s Libtayo FDA Approved as First Immunotherapy to Reduce Recurrence of High

The FDA has approved a new use of PD-1 inhibitor Libtayo (cemiplimab-rwlc) as a treatment for cutaneous squamous cell carcinoma (CSCC) that has a high risk of recurring after it has been treated with surgery and radiation. The approval makes Libtayo the first immunotherapy approved for use after surgery and radiation and may change how patients are treated earlier in their disease.

As a PD-1 inhibitor, Libtayo targets receptors on T cells and, in doing so, unleashes them so they recognize and attack cancer cells. The FDA had previously approved the monoclonal antibody as a treatment for metastatic and locally advanced CSCC, metastatic and locally advanced basal cell carcinoma (BCC) and certain types of non-small cell lung cancer. Libtayo, manufactured by Regeneron, is also being studied f