Libtayo (cemiplimab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	PD-L1 >= 1%, Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed