Regulatory approval

Published by the Food and Drug Administration.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed