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Zolbetuximab companion diagnostic - Roche Tissue Diagnostics

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Drug Profile

Zolbetuximab companion diagnostic - Roche Tissue Diagnostics

Alternative Names: IMAB-362 companion diagnostic - Roche Tissue Diagnostics; VENTANA CLDN18 (43-14A) assay for zolbetuximab - Roche Tissue Diagnostics; VYLOY companion diagnostic - Roche Tissue Diagnostics

Latest Information Update: 11 Sep 2024

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At a glance

  • Originator Roche Tissue Diagnostics
  • Developer Astellas Pharma; Roche Tissue Diagnostics
  • Class Monoclonal antibody diagnostics
  • Mechanism of Action Undefined mechanism
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Registered Gastric cancer
  • Preregistration Adenocarcinoma

Most Recent Events

  • 26 Jul 2024 Preregistration for Adenocarcinoma (Diagnosis) in European Union (unspecified route)
  • 26 Mar 2024 Registered for Gastric cancer (Diagnosis) in Japan (unspecified route)
  • 26 Mar 2024 Astellas in collaboration with Roche Diagnostics plans to launch zolbetuximab companion diagnostic for Gastric cancer (Diagnosis) in Japan

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