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
  • None
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]

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]

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] [5] [6]

Names

Zanidatamab is the international nonproprietary name. [7]

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

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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. 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. Retrieved 6 December 2024.
  5. "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
  6. "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.
  7. World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl: 10665/339768 .