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Trastuzumab deruxtecan - AstraZeneca/Daiichi Sankyo

Drug Profile

Trastuzumab deruxtecan - AstraZeneca/Daiichi Sankyo

Alternative Names: DS 8201; DS 8201a; ENHERTU; Enhertu; fam-trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki; T-DXd; VRN-101099

Latest Information Update: 12 Feb 2024

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At a glance

  • Originator Daiichi Sankyo Company
  • Developer AstraZeneca; Bristol-Myers Squibb; Daiichi Sankyo Company; Fox Chase Cancer Center; Medica Scientia Innovation Research; National Comprehensive Cancer Network; Puma Biotechnology; Seagen
  • Class 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.

    Yes - Gastric cancer; Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer; Gastric cancer; HER2 positive breast cancer; Non-small cell lung cancer
  • Preregistration Solid tumours
  • Phase II Adenocarcinoma; Biliary cancer; Colorectal cancer; Uterine cancer
  • Phase I/II Urogenital cancer

Most Recent Events

  • 06 Feb 2024 Daiichi Sankyo Company plans a phase I trial for Solid tumors (Late-stage-diseases, Metastatic-diseases, Combination therapy) (NCT06244485, DS3201-324)
  • 29 Jan 2024 Preregistration for Solid tumours (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (IV)
  • 29 Jan 2024 FDA assigns PDUFA action date of 30/05/2024 for Trastuzumab deruxtecan for HER 2-positive solid tumors (Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) (IV)
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