Zanidatamab
Medication
From Wikipedia, the free encyclopedia
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer.[2][5] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.[2][5][6] Zanidatamab is produced in Chinese hamster ovary cells.[2]
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | HER2 |
| Clinical data | |
| Trade names | Ziihera |
| Other names | ZW25, zanidatamab-hrii |
| AHFS/Drugs.com | Monograph |
| License data |
|
| Routes of administration | Intravenous infusion |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C5553H8526N1482O1726S36 |
| Molar mass | 124818.10 g·mol−1 |
The most common adverse reactions include diarrhea, infusion-related reaction, abdominal pain, and fatigue.[5]
Zanidatamab was approved for medical use in the United States in November 2024.[5][7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]
Medical uses
Zanidatamab is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test.[2][5]
Adverse effects
The US Food and Drug Administration prescribing information contains a boxed warning for embryo-fetal toxicity.[5]
The most common adverse reactions include diarrhea, infusion-related reactions, abdominal pain, and fatigue.[5]
History
Efficacy was evaluated in HERIZON-BTC-01 (NCT04466891), an open-label multicenter, single-arm trial in 62 participants with unresectable or metastatic HER2-positive (IHC3+) biliary tract cancer.[5] Participants were required to have received at least one prior gemcitabine-containing regimen in the advanced disease setting.[5]
The US Food and Drug Administration (FDA) granted the application for zanidatamab priority review, breakthrough therapy, and orphan drug designations.[5]
Society and culture
Legal status
Zanidatamab was approved for medical use in the United States in November 2024.[5][9][10]
In April 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Ziihera, intended for the treatment of adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer.[3] The applicant for this medicinal product is Jazz Pharmaceuticals Ireland Limited.[3] Zanidatamab was authorized for medical use in the European Union in June 2025.[3][4]
Names
Zanidatamab is the international nonproprietary name.[11]
Zanidatamab is sold under the brand name Ziihera.[2]
