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# NovaBridge Says FDA Open to Accelerated Approval for Givastomig
- URL: https://www.fdaweb.com/novabridge-says-fda-open-to-accelerated-approval-for-givastomig/
- Published: 2026-03-16T12:00:00.000Z
- Updated: 2026-09-14T13:35:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160824

FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following a recent Type B regulatory meeting. The company says written minutes from the meeting confirmed the agency’s willingness to consider accelerated approval for the drug in first-line treatment of patients with HER2-negative, Claudin 18.2–positive, PD-L1–positive gastroesophageal cancer.

NovaBridge plans to launch a registrational Phase 3 trial of givastomig in combination with immunochemotherapy as early as the fourth quarter of 2026\. The study is expected to use objective response rate as the primary endpoint to support a potential accelerated approval filing, with final design details to be finalized in discussions with regulators.

Givastomig is a bispecific antibody designed to target Claudin 18.2 on tumor cells while activating T cells through the 4-1BB immune signaling pathway, according to the company. The therapy is being developed as a potential first-in-class treatment for gastric and other gastrointestinal cancers expressing the Claudin 18.2 biomarker.

According to the company, data from a Phase 1b dose-expansion trial evaluating givastomig in combination with immunochemotherapy showed a 75% objective response rate among 52 evaluable patients. Responses were observed across a range of PD-L1 and Claudin 18.2 expression levels.

Investigators also reported a median progression-free survival of 16.9 months and an 82% six-month progression-free survival rate among 53 evaluable patients. The company says the therapy demonstrated favorable tolerability without evidence of dose-dependent toxicity.