Chemistry:Zanidatamab
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]
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] Zanidatamab was authorized for medical use in the European Union in June 2025.[8][9]
Names
Zanidatamab is the international nonproprietary name.[10]
Zanidatamab is sold under the brand name Ziihera.[1]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 Cite error: Invalid
<ref>tag; no text was provided for refs namedZiihera FDA label - ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer". 21 November 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2.
This article incorporates text from this source, which is in the public domain.
- ↑ "Advances in HER2-Targeted Therapies: From monoclonal antibodies to dual inhibitors developments in cancer treatment". Bioorganic Chemistry 151. October 2024. doi:10.1016/j.bioorg.2024.107695. PMID 39137598.
- ↑ "Cancer Accelerated Approvals". 1 October 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ "Novel Drug Approvals for 2024". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-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.
- ↑ 8.0 8.1 8.2 "Ziihera EPAR". 25 April 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/ziihera. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Ziihera PI". 30 June 2025. https://ec.europa.eu/health/documents/community-register/html/h1931.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
External links
- "Zanidatamab-hrii". https://www.cancer.gov/publications/dictionaries/cancer-drug/def/zanidatamab.
- "Zanidatamab (Code C130010)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI+Thesaurus&code=C130010.
- 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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