Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized cemiplimab as a monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in >= 50% of tumor cells), with no EGFR, ALK, or ROS1 aberrations. This indication is specifically for patients who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or patients with metastatic NSCLC.

This is written in the approval document as:

LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in >= 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.

Citation

Regeneron Ireland Designated Activity Company (DAC). Libtayo (cemiplimab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf. Revised January 2024. Accessed March 19, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Cemiplimab