Lazcluze (lazertinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

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

Regulatory approvals

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

Indication	Statements
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.	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