Regulatory approval

Published by the Health Canada.

Health Canada approved lazertinib in combination with amivantamab 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 as:

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.

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.

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