Libtayo (cemiplimab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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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 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: (i) locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or (ii) metastatic. 1
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
Organizations Biomarkers Cancer types Therapies
FDA (1) Wild type ALK, Wild type EGFR, Wild type ROS1 Non-Small Cell Lung Cancer Carboplatin, Cemiplimab, Pemetrexed
FDA (1) PD-L1 >= 50%, Wild type ALK, Wild type EGFR, dMMR Non-Small Cell Lung Cancer Cemiplimab