Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized gefitinib as a monotherapy treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating variants of EGFR-TK.

This is written in the approval document as:

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.

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Gefitinib