NovaBridge Biosciences Receives FDA Fast Track Designation for Givastomig in First-Line HER2-Negative Metastatic Gastric Cancer
The FDA granted Fast Track Designation to givastomig for the first-line treatment of HER2-negative metastatic gastric cancer, facilitating a more efficient development and review process. NovaBridge expects to initiate a registrational Phase 3 trial for the CLDN18.2 x 4-1BB bispecific antibody as early as Q4 2026, following confirmation of eligibility for the accelerated approval pathway.
Key figures
- Drug Name
- Givastomig (TJ033721 / ABL111)
- Phase Of Trial
- Phase 3
- Mechanism
- CLDN18.2 x 4-1BB bispecific antibody
- Indication
- HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA)
- Phase1b data presentation
- H2 2026
- Registrational trial start
- Q4 2026
AI analysis
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