# Afatinib

Afatinib (Giotrif, Boehringer Ingelheim International GmbH) has 2 EU-approved indications in 1 tumour type. 1 needs a biomarker result: EGFR (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Squamous only; Progressed on or after platinum-based chemotherapy |
| Activating EGFR mutation(s) | Monotherapy | Advanced | EGFR TKI-naïve |

## Products

### Giotrif

- Company: Boehringer Ingelheim International GmbH
- Target: Irreversible ErbB family inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB03
- EU approval: 25 Sep 2013
- Label revised: 11 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/giotrif-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/giotrif

Mechanism (SmPC section 5.1): Afatinib covalently binds to and irreversibly blocks signalling from homo- and heterodimers formed by ErbB family members EGFR, HER2, ErbB3, and ErbB4.

## Label wording

- **Afatinib** (Giotrif), Non-small cell lung cancer, advanced: “Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);” [SmPC](https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf)
- **Afatinib** (Giotrif), Non-small cell lung cancer, 2nd line, advanced: “Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/giotrif-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/afatinib