Iressa (gefitinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

AstraZeneca AB. Iressa (gefitinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf. Revised July 2023. Accessed March 7, 2024.

Regulatory approvals

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

Indication	Statements
IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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