Disitamab Vedotin For Injection

Indicated for the treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two lines of systemic chemotherapy. [1] HER2 overexpression is defined as a HER2 immunohistochemistry result of 2+ or 3+. [8]
This product is indicated for patients with HER2-overexpressing locally advanced or metastatic urothelial carcinoma who have previously received platinum-containing chemotherapy. HER2 overexpression is defined as a HER2 immunohistochemistry result of 2+ or 3+. [5-6] [9]
The above indication is conditionally approved based on the objective response rate results of a single-arm clinical trial. Full approval of the above indication will depend on whether the ongoing confirmatory clinical trials can confirm the clinical benefit of this product in the above population. [9]