Regulatory approval

Published by the Health Canada. Approved

LAZCLUZE (lazertinib) in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.

This is written in the approval document.

Citation

Janssen Inc. Lazcluze (lazertinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078792.PDF. Published March 2025. Accessed June 2025.

Therapeutic response

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

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