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.

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