Disitamab Vedotin: First Approval
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. Emma Deeks is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.
Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.
information about this Adis Drug Review can be found here
Disitamab vedotin (Aidixi®) is an antibody–drug conjugate
comprising a monoclonal antibody against human epidermal growth factor receptor
2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl
auristatin E. Disitamab vedotin is being developed by RemeGen for the treatment
of solid tumours, including gastric cancer. In June 2021, disitamab vedotin
received its first Biologics License Application (BLA) approval in China for
the treatment of patients with HER2-overexpressing (defined as IHC2+ or 3+) locally
advanced or metastatic gastric cancer (including gastroesophageal junction
adenocarcinoma) who have received at least two systemic chemotherapy regimens. Disitamab
vedotin as monotherapy or combination therapy is also in clinical development
for the treatment of other solid tumours globally, including urothelial cancer
in China and the USA, and biliary tract cancer, non-small cell lung cancer and Her2-positive
and low-expressing breast cancer in China. This article summarizes the
milestones in the development of disitamab vedotin leading to this first
approval for locally advanced or metastatic gastric cancer.
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