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Patritumab deruxtecan - Daiichi Sankyo Company

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Drug Profile

Patritumab deruxtecan - Daiichi Sankyo Company

Alternative Names: HER3-DXd; MK-1022; Patritumab-DX-8951 conjugate; U3-1402; U3-1402a

Latest Information Update: 03 Jul 2024

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At a glance

  • Originator Daiichi Sankyo Company
  • Developer Daiichi Sankyo Company; SCRI Development Innovations; SOLTI Breast Cancer Research Group
  • Class Alkaloids; Antibodies; Antineoplastics; Camptothecins; Drug conjugates; Immunoconjugates
  • Mechanism of Action DNA topoisomerase I inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Non-small cell lung cancer
  • Phase II Breast cancer; Colorectal cancer; Solid tumours
  • Phase I/II HER2 positive breast cancer

Most Recent Events

  • 27 Jun 2024 The US FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) to inspection findings at third-party manufacturer
  • 25 Apr 2024 Samsung Medical Center plans a phase II Basket trial for Solid tumours (Late-stage disease, Metastatic disease, Inoperable/Unresectable) in South Korea (IV, Infusion) (NCT06383884)
  • 07 Apr 2024 Pharmacodynamics data from a preclinical study in hepatoblastoma and rhabdomyosarcoma presented at the 115th Annual Meeting of the American Association for Cancer Research (AACR-2024)

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