Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2022-11-08	Food and Drug Administration	Indication received traditional approval.