FDA Approves Libtayo for Advanced Basal Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc), a PD-1 inhibitor, as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC). The agency granted full approval for locally advanced BCC and accelerated approval for metastatic BCC, following a Priority Review.

Libtayo is now approved for patients with advanced stages of both the two most common skin cancers in the U.S. Previously, in 2018, the drug received its first U.S. approval for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation.

Basal cell carcinoma is the most common cancer in the U.S., with approximately two million new cases diagnosed annually. While most BCCs are diagnosed early and cured with surgery or radiation, a small proportion of tumors can become advanced and penetrate deep into surrounding tissues or spread to other parts of the body. Libtayo demonstrated clinical benefit in a pivotal trial for patients with advanced BCC previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.

The approvals are based on data showing Libtayo’s efficacy in treating advanced BCC. Continued approval for the metastatic indication may be contingent upon the verification of clinical benefit through further trials. The FDA's Priority Review designation is for medicines that offer significant improvements in treating serious conditions.