Decision: Favourable

Decisions Table

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.

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