FDA Fast Track Designation for Givastomig in 1L HER2-Neg Metastatic Gastric Cancer

“Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a broad patient population, with marked improvement relative to historical benchmarks for the standard of care. Fast Track Designation, combined with FDA’s prior confirmation of accelerated approval pathway eligibility, enables a more efficient path to a registrational Phase 3 trial, reflecting givastomig’s promise as a first-in-class and best-in-class CLDN18.2-directed therapy for gastric cancer. We look forward to ongoing dialog with the FDA to bring givastomig to patients as quickly as possible.”