Zanidatamab

Last updated

Zanidatamab
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target HER2
Clinical data
Trade names Ziihera
Other namesZW25, 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 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]

Contents

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

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

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. [8] The applicant for this medicinal product is Jazz Pharmaceuticals Ireland Limited. [8]

Names

Zanidatamab is the international nonproprietary name. [9]

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

References

  1. 1 2 3 4 5 6 "Ziihera- zanidatamab-hrii injection, powder, lyophilized, for solution". DailyMed. 20 November 2024. Retrieved 28 November 2024.
  2. 1 2 3 4 5 6 7 8 9 10 11 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  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. Archived from the original on 27 October 2021. Retrieved 6 December 2024.
  5. ↑ New Drug Therapy Approvals 2024. U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original (PDF) on 21 January 2025. Retrieved 21 January 2025.
  6. ↑ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 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. 1 2 "Ziihera EPAR". European Medicines Agency (EMA). 25 April 2025. Retrieved 2 May 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ↑ 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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