Lazcluze (lazertinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib