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Datopotamab deruxtecan - Daiichi Sankyo Company/Astrazeneca

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Drug Profile

Datopotamab deruxtecan - Daiichi Sankyo Company/Astrazeneca

Alternative Names: Dato-DXd; Datopotamab deruxtecan-dlnk; DATROWAY; DS 1062a; DS-1062; S-1062a; TROP2-directed ADC

Latest Information Update: 23 Jan 2025

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At a glance

  • Originator Daiichi Sankyo Company
  • Developer AstraZeneca; Daiichi Sankyo Company; Merck & Co
  • Class Alkaloids; Antineoplastics; Camptothecins; Drug conjugates; Immunoconjugates; Monoclonal antibodies
  • 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

  • Registered HER2 negative breast cancer
  • Preregistration Non-small cell lung cancer
  • Phase III Triple negative breast cancer
  • Phase II Solid tumours
  • Phase I/II Gastric cancer; Urogenital cancer

Most Recent Events

  • 17 Jan 2025 Registered for HER2-negative-breast-cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (IV)
  • 13 Jan 2025 FDA assigns PDUFA action date of 12/07/2025 for datopotamab deruxtecan for Non small cell lung cancer
  • 08 Jan 2025 Phase I development is ongoing in in Non-small-cell-lung-cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in France, Turkey, Poland (IV, Infusion)

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