Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized (from mouse) |
Target | HER2 |
Clinical data | |
Trade names | Ziihera |
Other names | ZW25, zanidatamab-hrii |
License data |
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Routes of administration | Intravenous infusion |
Drug class | Antineoplastic |
ATC code |
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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 name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1] [2] It is an IgG-like bispecific HER2-directed antibody. [1] [2] [3] Zanidatamab is produced in Chinese hamster ovary cells. [1]
The most common adverse reactions include diarrhea, infusion-related reaction, abdominal pain, and fatigue. [2]
Zanidatamab was approved for medical use in the United States in November 2024. [2] [4]
Zanidatamabis 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. [1] [2]
The US Food and Drug Administration prescribing information contains a boxed 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 prior gemcitabine-containing regimen in the advanced disease setting. [2]
The US Food and Drug Administration (FDA) granted the application for zanidatamab priority review, breakthrough therapy, and orphan drug designations. [2]
Zanidatamab was approved for medical use in the United States in November 2024. [2] [5] [6]
Zanidatamab is the international nonproprietary name. [7]
Zanidatamab is sold under the brand name Ziihera. [1]
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