Lorbrena (lorlatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Pfizer Canada ULC. Lorbrena (lorlatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00077541.PDF. Revised October 2024. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
LORBRENA (lorlatinib) is indicated as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).	1
LORBRENA (lorlatinib) is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or aectinib.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Lorlatinib
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Lorlatinib