Regulatory approval

Published by the Health Canada.

Health Canada approved gefitinib for the first line treatment of patients with locally advanced (not amenable to curative therapy)or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK

This is written in the approval document as:

IRESSA (gefitinib) is indicated for the first line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK

Citation

AstraZeneca Canada Inc. Iressa (gefitinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00060650.PDF. Revised March 2021. 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 Exon 19 (Deletion) Non-Small Cell Lung Cancer Gefitinib
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Gefitinib
Sensitivity (+) EGFR oncogenic variants Non-Small Cell Lung Cancer Gefitinib