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Nivolumab companion diagnostic - Dako/ONO Pharmaceutical

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Drug Profile

Nivolumab companion diagnostic - Dako/ONO Pharmaceutical

Alternative Names: PD-L1 IHC 28-8 pharmDx

Latest Information Update: 13 Dec 2024

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At a glance

  • Originator Dako A/S; Ono Pharmaceutical
  • Developer Agilent Technologies; Dako A/S; Ono Pharmaceutical
  • Class Diagnostic agents
  • 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 Gastric cancer; Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Oesophageal cancer; Urogenital cancer

Most Recent Events

  • 10 Dec 2024 Agilent Technologies receives a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx
  • 05 Apr 2022 Registered for Oesophageal cancer (Diagnosis, Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease, Recurrent, Late-stage disease) in European Union (unspecified route)
  • 05 Apr 2022 Registered for Urogenital cancer (Diagnosis, Adjuvant therapy) in European Union (unspecified route)

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