Regulatory approval

Published by the Health Canada. Approved

Health Canada approved lorlatinib 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.

This is written in the approval document as:

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.

Citation

Pfizer Canada ULC. Lorbrena (lorlatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083472.PDF. Revised February 2026. Accessed April 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	v::ALK	Non-Small Cell Lung Cancer	Lorlatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals