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Cemiplimab companion diagnostic - Roche Tissue Diagnostics

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Drug Profile

Cemiplimab companion diagnostic - Roche Tissue Diagnostics

Alternative Names: Libtayo companion diagnostic - Roche Tissue Diagnostics; REGN-2810 companion diagnostic - Roche Tissue Diagnostics; SAR-439684 companion diagnostic - Roche Tissue Diagnostics; VENTANA PD-L1 (SP263) Assay for cemiplimab - Roche Tissue Diagnostics

Latest Information Update: 25 Mar 2023

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At a glance

  • Originator 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

  • Marketed Non-small cell lung cancer

Most Recent Events

  • 06 Mar 2023 Launched for Non-small cell lung cancer (Diagnosis) in USA (unspecified route)
  • 05 Mar 2023 Registered for Non-small cell lung cancer (Diagnosis) in USA (unspecified route)
  • 19 Sep 2022 VENTANA PD-L1 (SP 263) Assay receives a CE IVD approval as a companion diagnostic for cemiplimab in Non-small cell lung cancer

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