Libtayo (cemiplimab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Regeneron Pharmaceuticals, Inc. Libtayo (cemiplimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf. Revised February 2021. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) >= 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic.

1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR, dMMR	Non-Small Cell Lung Cancer	Cemiplimab