Regulatory approval

Published by the Health Canada.

Health Canada approved afatinib for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naïve patients with metastatic adenocarcinoma of the lung with activating EGFR mutation(s).

This is written in the approval document as:

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

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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EGFR somatic variants Non-Small Cell Lung Cancer Afatinib
Sensitivity (+) EGFR oncogenic variants Non-Small Cell Lung Cancer Afatinib