U.S. License Holder:

Regeneron Pharmaceuticals

Date of License:

September-28-2018

FDA-Approved Indications

LIBTAYO (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody indicated:

Cutaneous Squamous Cell Carcinoma (CSCC)- For the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation;

Basal Cell Carcinoma (BCC)- For the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; For the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate;

Non-Small Cell Lung Cancer (NSCLC)- For the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) greater than or equal to 50 percent] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.