Regulatory approval

Published by the European Medicines Agency. Approved

LIBTAYO in combination with platinum_based chemotherapy is indicated for the first_line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-03-24	European Medicines Agency	Indication received approval from the European Commission.