Iressa (gefitinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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