Posted by Michael Wonder on 17 Jun 2026
NovaBridge Biosciences receives FDA fast track designation for givastomig in first-line HER2 negative metastatic gastric cancer
16 June 2026 - NovaBridge Biosciences today announced that the US FDA has granted fast track designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2 negative advanced or metastatic gastroesophageal adenocarcinomas whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive.
Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody.
