# Tucatinib

Tucatinib (Tukysa, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HER2 (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3rd line+, advanced | After at least 2 prior anti-HER2 treatment regimens |

## Products

### Tukysa

- Company: Pfizer Europe MA EEIG
- Target: HER2 tyrosine kinase inhibitor
- Class: Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
- ATC: L01EH03
- EU approval: 11 Feb 2021
- Label revised: 25 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tukysa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa

Mechanism (SmPC section 5.1): Tucatinib selectively inhibits HER2 tyrosine kinase, blocking downstream signaling and cell proliferation while inducing death in HER2-driven tumor cells.

## Label wording

- **Tucatinib** (Tukysa), Breast cancer, 3rd line+, advanced: “TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tukysa-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/tucatinib