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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Gefitinib
HC (1) EGFR p.L858R Non-Small Cell Lung Cancer Gefitinib
HC (1) EGFR oncogenic variants Non-Small Cell Lung Cancer Gefitinib