U.S. License Holder:
Regeneron Pharmaceuticals
Date of License:
September-28-2018
Last Update:
January-23-2023
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): In combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic; As a single agent for the first-line treatment of adult 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.