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.
1.Two arms bind two different HER2 epitopes (ECD2 and ECD4) on one or neighbouring receptors
- 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
- JazzCares
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- 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.
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- Jan 2023DesignationUS
Breakthrough Therapy designation, HER2+ biliary tract cancer source
- 20 Nov 2024ApprovalUS
Accelerated approval, previously treated HER2+ (IHC3+) biliary tract cancer (HERIZON-BTC-01) source
- Dec 2025Filing / dealUS
First-line HER2+ gastro-oesophageal adenocarcinoma (HERIZON-GEA-01) submission source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | HER2+ (IHC 3+) unresectable/metastatic biliary tract cancer, previously treated |
| 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductTislelizumab
Shares HERIZON-GEA-01, Biomarker-directed first-line quadruplets in gastric cancer, BeOne Medicines (formerly BeiGene), Oesophageal cancer.
- TrialToGA
Shares HER2 sequence in gastric cancer: zanidatamab/trastuzumab + chemo ± PD-1 → T-DXd, HER2, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
- TrialDESTINY-Gastric04
Shares HER2 sequence in gastric cancer: zanidatamab/trastuzumab + chemo ± PD-1 → T-DXd, HER2, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
- ProductZenocutuzumab
Shares Bispecific antibodies, Receptor tyrosine kinase activation, Biliary tract cancer (cholangiocarcinoma), HER2.
- ProductZolbetuximab
Shares Jeeyun Lee, Biomarker-directed first-line quadruplets in gastric cancer, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
- TargetClaudin 18.2
Shares Jeeyun Lee, Biomarker-directed first-line quadruplets in gastric cancer, Biliary tract cancer (cholangiocarcinoma), Oesophageal cancer.
- TrialCheckMate 649
Shares Biomarker-directed first-line quadruplets in gastric cancer, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer.
- ProductTrastuzumab biosimilars
Shares HER2, HER2-positive breast cancer, Gastric & gastro-oesophageal junction cancer.