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Trastuzumab deruxtecan - AstraZeneca/Daiichi Sankyo

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Drug Profile

Trastuzumab deruxtecan - AstraZeneca/Daiichi Sankyo

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

Latest Information Update: 26 Sep 2025

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At a glance

  • Originator Daiichi Sankyo Company
  • Developer AstraZeneca; Bristol-Myers Squibb; Daiichi Sankyo Company; Medica Scientia Innovation Research; 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; Solid tumours
  • Registered Adenocarcinoma
  • Phase III Biliary cancer; Endometrial cancer; Ovarian cancer
  • Phase II Colorectal cancer; Uterine cancer
  • Phase I/II Urogenital cancer

Most Recent Events

  • 24 Sep 2025 Preregistration for Breast cancer (Metastatic disease, Late-stage disease, Combination therapy, First-line therapy) in USA (IV)
  • 24 Sep 2025 FDA assigns PDUFA action date of (31/03/2025) for trastuzumab deruxtecan for Breast cancer
  • 24 Sep 2025 Trastuzumab deruxtecan receives priority review status for Breast cancer (Combination therapy, Metastatic disease, First-line therapy, Late-stage disease) in USA

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