FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer Concluded
“We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “This important regulatory milestone builds on compelling Phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and to bringing givastomig to patients as quickly as possible.”
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“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