Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized 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.

This is written in the approval document as:

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.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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