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: 21 Jul 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

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

17 Jul 2025 Trastuzumab deruxtecan receives Breakthrough Therapy status for HER2-positive-breast-cancer (Metastatic disease, Inoperable/Unresectable, First-line therapy, Combination therapy) in USA
15 Jun 2025 Daiichi Sankyo plans a phase III trial for Endometrial cancer (First line therapy) (IV), in August 2025 (NCT07022483)
02 Jun 2025 Efficacy and adverse events data from phase III DESTINY-Breast09 trial in Breast cancer released by AstraZeneca

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