Zanidatamab

Zanidatamab
Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	HER2
Clinical data
Trade names	Ziihera
Other names	ZW25, zanidatamab-hrii
License data	US DailyMed: Zanidatamab;
Routes of; administration	Intravenous infusion
Drug class	Antineoplastic
ATC code	L01FD07 (WHO) ;
Legal status
Legal status	US: ℞-only;
Identifiers
CAS Number	2169946-15-8;
DrugBank	DB15471;
UNII	Z20OC92TDI;
KEGG	D12011;
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 directed against two non-overlapping domains of HER2.^[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] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[5]

Medical uses

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]

Adverse effects

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]

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.^[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]

Society and culture

Legal status

Zanidatamab was approved for medical use in the United States in November 2024.^[2]^[6]^[7]

Names

Zanidatamab is the international nonproprietary name.^[8]

Zanidatamab is sold under the brand name Ziihera.^[1]

References

^ ^a ^b ^c ^d ^e ^f "Ziihera- zanidatamab-hrii injection, powder, lyophilized, for solution". DailyMed. 20 November 2024. Retrieved 28 November 2024.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k "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. 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. 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.
^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
^ "Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)" (Press release). Jazz Pharmaceuticals. 20 November 2024. Retrieved 23 November 2024 – via PR Newswire.
^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

External links

"Zanidatamab-hrii". NCI Drug Dictionary.
"Zanidatamab (Code C130010)". NCI Thesaurus.
Clinical trial number NCT04466891 for "A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (HERIZON-BTC-01)" at ClinicalTrials.gov

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[Ziihera_FDA_label-1] ^ ^a ^b ^c ^d ^e ^f "Ziihera- zanidatamab-hrii injection, powder, lyophilized, for solution". DailyMed. 20 November 2024. Retrieved 28 November 2024.

[FDA_20241121-2] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k "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. Retrieved 23 November 2024. This article incorporates text from this source, which is in the public domain.

[Bhagyalalitha_2024-3] 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.

[4] "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.

[5] 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.

[Novel_Drug_Approvals_for_2024-6] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.

[7] "Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)" (Press release). Jazz Pharmaceuticals. 20 November 2024. Retrieved 23 November 2024 – via PR Newswire.

[8] World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.

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