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 of Zanidatamab
Biomarker requirementRegimenSettingConditions
Biliary tract cancer1
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After at least one prior line of systemic therapy
Full text of section 4.1 (therapeutic indications)

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).

Label history

2 changes to the Ziihera label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes