HER2 in biliary tract cancer

1 EU-approved indication in biliary tract cancer needs a HER2 result: zanidatamab (2nd line, advanced).

Line of therapy

Approved indications, Biliary tract cancer
DrugBiomarker requirementRegimenSettingConditions
HER21
Zanidatamab
Ziiheraconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After at least one prior line of systemic therapy

Tumour-agnostic approvals1

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options

2 approvals for BTC need no biomarker and apply whatever the result. All approvals for BTC

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Zanidatamab (Ziihera)
    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).