Decision: Favourable
Study Title:
Diagnostic Protocol for VENTANA FGFR2b (FPR2-D) Assay for Amgen Study 20210096 (CTIMP: A Randomized, Multi-Center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab plus Chemotherapy versus Placebo plus Chemotherapy in Subjects with Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression)
NREC Code:
23-NREC-MD-012
Decision:
Favourable
Meeting Date:
20/04/2023
Study Type:
MD Application
Principal Investigator:
Dr Maeve Lowery
PI Institution:
St. James's Hospital
Sponsor:
Ventana Medical Systems Inc.