Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 50%, Wild type ALK, Wild type EGFR, and dMMR status confers therapeutic sensitivity to Cemiplimab in patients with Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration granted approval to cemiplimab 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Regeneron Pharmaceuticals, Inc. Libtayo (cemiplimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf. Revised April 2024. Accessed October 30, 2024. 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.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-02-22	Food and Drug Administration	Indication received traditional approval.