Disitamab Vedotin: First Approval

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; Seagen has the right to develop disitamab vedotin globally outside of RemeGen’s territory. 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 HER2-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.