Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	EGFR TKD activating variants	Non-Small Cell Lung Cancer	Gefitinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2009-06-24	European Medicines Agency	Indication received approval from the European Commission.