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drugsProductApproved2024🇪🇺🇬🇧🇨🇳

Zanidatamab

Zanidatamab (Ziihera) is an antibody that grabs HER2 at two different spots, approved for HER2+ bile duct cancer.

Accelerated approval November 2024 for HER2+ biliary tract cancer (HERIZON-BTC-01). HERIZON-GEA-01 phase 3 in first-line HER2+ gastro-oesophageal cancer with chemotherapy ± tislelizumab was positive (2025). Jazz (ex-Asia) and BeOne. Biparatopic binding drives receptor clustering and internalisation, the basis of the ADC zanidatamab zovodotin.

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Zanidatamab bound to HER2 (PDB 8FFJ), backbone trace
RCSB PDB
Mechanism, step by step
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1.Two arms bind two different HER2 epitopes (ECD2 and ECD4) on one or neighbouring receptors

Modality
Biparatopic bispecific antibody (HER2)
Mechanism
Binds ECD2 and ECD4 of HER2 simultaneously; clustering, internalisation, ADCC.
Brand / code
Ziihera
Dosing & schedule
Route
IV infusion
Schedule
20 mg/kg every 2 weeks
Dose modifications
Hold for LVEF decline or grade 3 diarrhoea
Monitoring
LVEF at baseline and every 3 months; infusion reactions; diarrhoea

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA accelerated approval for HER2-positive biliary tract cancer (2024).

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
MHRA-licensed 2025 for HER2-positive biliary tract cancer; NICE appraisal in progress.

Sources: NICE search: zanidatamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. Jan 2023DesignationUS

    Breakthrough Therapy designation, HER2+ biliary tract cancer source

  2. 20 Nov 2024ApprovalUS

    Accelerated approval, previously treated HER2+ (IHC3+) biliary tract cancer (HERIZON-BTC-01) source

  3. Dec 2025Filing / dealUS

    First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission source

Approvals

RegionYearIndication
US2024HER2+ (IHC 3+) unresectable/metastatic biliary tract cancer, previously treated

Safety

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Toxicity profile
Adverse event
Diarrhoea
Infusion-related reactions
Abdominal pain
Fatigue
Nausea
Left ventricular dysfunction

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
30 studies15 recruiting24 Phase 26 Phase 3
Search “Zanidatamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Zanidatamab
intervention: Zanidatamab
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend17 papers in the last 12 months+13% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Zanidatamab" OR ABSTRACT:"Zanidatamab" OR TITLE:"Ziihera" OR ABSTRACT:"Ziihera") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Zanidatamab, not a curated reading list.

Connected

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