Regulatory approval

Published by the Health Canada. Approved

GIOTRIF (afatinib) is indicated as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naive patients with metastatic adenocarcinoma of the lung with activating EGFR mutation(s).

This is written in the approval document.

Citation

Boehringer Ingelheim (Canada) Ltd. Giotrif (afatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00051644.PDF. Revised June 2019. Accessed June 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	EGFR Somatic variants	Non-Small Cell Lung Cancer	Afatinib
HC (1)	EGFR activating variants	Non-Small Cell Lung Cancer	Afatinib

Contributions

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