# Zanidatamab

Zanidatamab (Ziihera, Jazz Pharmaceuticals Ireland Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HER2 (1).

## Approved indications

### Biliary tract cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After at least one prior line of systemic therapy |

## Products

### Ziihera

- Company: Jazz Pharmaceuticals Ireland Limited
- Target: Dual HER2-targeted bispecific antibody
- Class: HER2 (human epidermal growth factor receptor 2) inhibitors
- ATC: L01FD07
- EU approval: 27 Jun 2025
- Label revised: 16 Jun 2026
- Status: conditional approval, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ziihera-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ziihera

Mechanism (SmPC section 5.1): Binds extracellular domains 2 and 4 of HER2, inducing receptor internalization, CDC, ADCC, and ADCP to inhibit tumor growth and cause tumor cell death.

## Label wording

- **Zanidatamab** (Ziihera), Biliary tract cancer, 2nd line, advanced: “Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ziihera-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/zanidatamab