Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized cemiplimab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in >= 1% 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 indication is based on Study 16113, a randomized, multi-center, double-blind, active-controlled trial. The chemotherapy used in this study consisted of either carboplatin or cisplatin in combination with paclitaxel or pemetrexed.

This is written in the approval document as:

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.

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 >= 1%, Wild type ALK, Wild type EGFR, Wild type ROS1	Non-Small Cell Lung Cancer	Carboplatin, Cemiplimab, Pemetrexed