Disitamab Vedotin approved in china as first line therapy for HER2 expressing urothelial carcinoma

CAR-T Digest - August 2020

10 April 2026: Disitamab Vedotin approved in china as first line therapy for HER2 expressing urothelial carcinoma

RemeGen has received approval in China for disitamab vedotin (RC48, Aidixi) in combination with toripalimab as a first-line treatment for patients with HER2-expressing locally advanced or metastatic urothelial carcinoma
The approval is supported by results from the Phase 3 RC48-C016 randomized, multicenter trial, which demonstrated that the combination therapy significantly outperformed standard platinum-based chemotherapy in the first-line setting
The study reported meaningful clinical benefits, including a median progression-free survival of 13.1 months and overall survival of 31.5 months, alongside high response rates and consistent efficacy across HER2 expression levels, including HER2-low patients
With improved efficacy and a favorable safety profile compared to chemotherapy, this combination therapy is poised to redefine first-line treatment strategies for advanced urothelial carcinoma and address significant unmet clinical needs
This milestone establishes disitamab vedotin as the first HER2-targeted ADC approved globally for first-line use in advanced urothelial carcinoma, expanding its role beyond previously approved later-line settings