# Gefitinib

Gefitinib (Iressa, AstraZeneca AB) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EGFR (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Activating mutations of EGFR-TK | Monotherapy | Advanced | - |

## Products

### Iressa

- Company: AstraZeneca AB
- Target: EGFR tyrosine kinase inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB01
- EU approval: 24 Jun 2009
- Label revised: 17 Jul 2023
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/iressa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/iressa

Mechanism (SmPC section 5.1): Gefitinib is a selective small-molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase domain, inhibiting growth in tumours with sensitising EGFR mutations.

## Label wording

- **Gefitinib** (Iressa), Non-small cell lung cancer, advanced: “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 (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/gefitinib