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.

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