Zanidatamab
| 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 |
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer.[1][4] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.[1][4][5] Zanidatamab is produced in Chinese hamster ovary cells.[1]
The most common adverse reactions include diarrhea, infusion-related reaction, abdominal pain, and fatigue.[4]
Zanidatamab was approved for medical use in the United States in November 2024.[4][6] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
- ^ a b c d "Ziihera- zanidatamab-hrii injection, powder, lyophilized, for solution". DailyMed. 20 November 2024. Retrieved 28 November 2024.
- ^ Cite error: The named reference
Ziihera EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
Ziihera PIwas invoked but never defined (see the help page). - ^ a b c d "FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer". U.S. Food and Drug Administration (FDA). 21 November 2024. Archived from the original on 21 November 2024. Retrieved 23 November 2024. This article incorporates text from this source, which is in the public domain.
- ^ Bhagyalalitha M, Handattu Shankaranarayana A, Arun Kumar S, Singh M, Pujar KG, Bidye D, et al. (October 2024). "Advances in HER2-Targeted Therapies: From monoclonal antibodies to dual inhibitors developments in cancer treatment". Bioorganic Chemistry. 151: 107695. doi:10.1016/j.bioorg.2024.107695. PMID 39137598.
- ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 27 October 2021. Retrieved 6 December 2024.
- ^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.