Osimertinib companion diagnostic - AstraZeneca/Roche

Drug Profile

Osimertinib companion diagnostic - AstraZeneca/Roche

Alternative Names: cobas EGFR Mutation Test v2 (US-IVD); Mereletinib companion diagnostic - AstraZeneca/Roche

Latest Information Update: 28 Nov 2017

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At a glance

  • Originator AstraZeneca; Roche
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Non-small cell lung cancer

Most Recent Events

  • 29 Sep 2016 US FDA approves Osimertinib companion diagnostic for use with plasma samples for Non-small cell lung cancer (Diagnosis) in USA
  • 13 Nov 2015 Registered for Non-small cell lung cancer (Diagnosis) in USA - first global approval
  • 30 Jul 2015 Preregistration for Non-small cell lung cancer in USA
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