| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (frommouse) |
| Target | HER2 |
| Clinical data | |
| Trade names | Ziihera |
| Other names | ZW25, zanidatamab-hrii |
| 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 |
Zanidatamab, sold under the brand nameZiihera, is ahumanized monoclonal antibody used for the treatment of HER2-positivebiliary tract cancer.[1][2] It is an IgG-likebispecific HER2-directed antibody directed against two non-overlapping domains of HER2.[1][2][3] Zanidatamab is produced inChinese hamster ovary cells.[1]
The most common adverse reactions includediarrhea,infusion-related reaction,abdominal pain, andfatigue.[2]
Zanidatamab was approved for medical use in the United States in November 2024.[2][4] The USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[5]
Zanidatamabisindicated for the treatment of adults with previously treated, unresectable ormetastatic HER2-positive (IHC 3+)biliary tract cancer, as detected by an FDA-approved test.[1][2]
The USFood and Drug Administration prescribing information contains aboxed warning for embryo-fetal toxicity.[2]
The most common adverse reactions include diarrhea, infusion-related reactions, abdominal pain, and fatigue.[2]
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.[2] Participants were required to have received at least one priorgemcitabine-containing regimen in the advanced disease setting.[2]
The USFood and Drug Administration (FDA) granted the application for zanidatamabpriority review,breakthrough therapy, andorphan drug designations.[2]
Zanidatamab was approved for medical use in the United States in November 2024.[2][6][7]
Zanidatamab is theinternational nonproprietary name.[8]
Zanidatamab is sold under the brand name Ziihera.[1]
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