Datopotamab Deruxtecan: 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. Hannah Blair is a salaried 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 

Datopotamab deruxtecan (DATROWAY®) is a trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate being developed by Daiichi Sankyo and AstraZeneca for the treatment of solid tumours. On 27 December 2024, datopotamab deruxtecan was approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative unresectable or recurrent breast cancer after prior chemotherapy. The drug has since been approved on 17 January 2025 in the USA for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Datopotamab deruxtecan has also received a positive opinion in the EU. Regulatory review of datopotamab deruxtecan in breast cancer is underway in Canada and China. This article summarizes the milestones in the development of datopotamab deruxtecan leading to this first approval for the treatment of HR positive, HER2 negative breast cancer.

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