Zanidatamab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here.

Abstract

Zanidatamab (ZIIHERA^®; zanidatamab- hrii), a bi-specific antibody targeting two non-overlapping epitopes of the human epidermal growth factor receptor 2 (HER2) protein, is being developed by Jazz Pharmaceuticals and BeiGene Ltd under license agreements from Zymeworks Inc., the developer of the molecule, for the treatment of HER2-expressing solid tumours. This article summarizes the milestones in the development of zanidatamab leading to this first accelerated approval for use in adults with previously treated, unresectable or metastatic HER2+ (IHC3+) biliary tract cancer (BTC), as detected by an FDA-approved test. 

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