# Dacomitinib

Dacomitinib (Vizimpro, Pfizer Europe MA EEIG) 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 |
|---|---|---|---|
| EGFR-activating mutation | Monotherapy | 1st line, advanced | - |

## Products

### Vizimpro

- Company: Pfizer Europe MA EEIG
- Target: Pan-HER kinase inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB07
- EU approval: 2 Apr 2019
- Label revised: 17 Dec 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/vizimpro-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/vizimpro-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro

Mechanism (SmPC section 5.1): Dacomitinib selectively and irreversibly binds to HER family receptors (EGFR/HER1, HER2, and HER4) to provide prolonged inhibition, including against mutated EGFR.

## Label wording

- **Dacomitinib** (Vizimpro), Non-small cell lung cancer, 1st line, advanced: “Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vizimpro-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/dacomitinib