Regulatory approval

Published by the European Medicines Agency. Approved

Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

This is written in the approval document.

Citation

Janssen Cilag International NV. Lazcluze (lazertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf. Revised January 2025. Accessed September 8, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib
EMA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib

Contributions

Date	Contributor	Description
2025-09-08	Van Allen lab	On 2025-03-17, the EMA provided approval to Lazcluze (lazertinib) for the therapeutic indication of lazertinib in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
2025-01-20	European Medicines Agency	Indication received approval from the European Commission.