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Trastuzumab deruxtecan companion diagnostic - Daiichi Sankyo/Roche

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Drug Profile

Trastuzumab deruxtecan companion diagnostic - Daiichi Sankyo/Roche

Alternative Names: [fam-] trastuzumab deruxtecan companion diagnostic - Daiichi Sankyo/Roche; HER2 low companion diagnostic test - Daiichi Sankyo/Roche; PATHWAY HER2 (4B5) test

Latest Information Update: 07 Feb 2025

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At a glance

  • Originator Roche
  • Developer Daiichi Sankyo Company; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed HER2 positive breast cancer; Non-small cell lung cancer

Most Recent Events

  • 31 Jan 2025 US FDA approves label expansion for HR-positive, HER2-ultralow Breast cancer (Diagnosis)
  • 12 Aug 2022 Launched for Non-small cell lung cancer (Diagnosis) in USA
  • 12 Aug 2022 Registered for Non-small cell lung cancer (Diagnosis) in USA

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