USFDAJun 16, 2026, 07:01 AM
NovaBridge Receives FDA Fast Track for Givastomig in Gastric Cancer
AI Summary
NovaBridge Biosciences announced that the FDA has granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas. This designation aims to accelerate the development and review of therapies for serious conditions with unmet medical needs. The company expects to begin a registrational Phase 3 trial as early as Q4 2026 and present detailed Phase 1b data in H2 2026.
Key Highlights
- NovaBridge Biosciences received FDA Fast Track Designation for givastomig.
- Designation is for givastomig in first-line HER2-negative metastatic gastric cancer.
- Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody.
- Registrational Phase 3 trial is expected to begin as early as Q4 2026.
- Detailed Phase 1b data is expected to be presented at a major medical conference in H2 2026.
- Fast Track Designation facilitates accelerated development and review for serious conditions.
- It may enable more frequent FDA interactions, Rolling Review, Priority Review, and Accelerated Approval.
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