Datopotamab deruxtecan

Datopotamab deruxtecan
Clinical data
Trade namesDatroway
Other namesDS-1062, Dato-DXd, datopotamab deruxtecan-dlnk
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Datopotamab deruxtecan, sold under the brand name Datroway, is an anti-cancer medication used for the treatment of breast cancer.[1][2] It is a Trop-2-directed antibody and topoisomerase inhibitor antibody-drug conjugate.[1][2]

The most common adverse reactions, including laboratory abnormalities, include stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.[2]

Datopotamab deruxtecan was approved for medical use in the United States in January 2025.[2]

Medical uses

Datopotamab deruxtecan is indicated for the treatment of adults with unresectable or metastatic, hormone receptor positive, human epidermal growth factor receptor 2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.[2]

Side effects

Datopotamab deruxtecan is associated with a range of adverse events.[3][4] Stomatitis is the most common severe event (13.88%).[4] Other side effects include pneumonitis, infusion-related reactions, oral mucositis, and ocular surface events.[3]

History

Efficacy was evaluated in TROPION-Breast01 (NCT05104866), a multicenter, open-label, randomized trial.[2] Participants must have experienced disease progression, been deemed unsuitable for further endocrine therapy, and have received one or two lines of prior chemotherapy for unresectable or metastatic disease.[2] Participants were excluded for a history of ILD/pneumonitis requiring steroids, ongoing ILD/pneumonitis, clinically active brain metastases, or clinically significant corneal disease.[2] Participants also were excluded for ECOG performance status >1.[2] Randomization was stratified by previous lines of chemotherapy, prior CDK4/6 inhibitor treatment, and geographical region.[2] A total of 732 patients were randomized (1:1) to datopotamab deruxtecan-dlnk (n=365) or investigator's choice of chemotherapy (n=367); eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%).[2]

Society and culture

Datopotamab deruxtecan was approved for medical use in the United States in January 2025.[2][5] In December 2024, the US Food and Drug Administration granted the application for datopotamab deruxtecan breakthrough therapy designation.[6]

In January 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Datroway, intended for the treatment of breast cancer.[7] The applicant for this medicinal product is Daiichi Sankyo Europe GmbH.[7]

Names

Datopotamab deruxtecan is the international nonproprietary name,[8] and the United States Adopted Name.[9]

Datopotamab deruxtecan is sold under the brand name Datroway.[1]

References

  1. 1 2 3 4 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf
  2. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer". U.S. Food and Drug Administration (FDA). 17 January 2025. Retrieved 19 January 2025. Public Domain This article incorporates text from this source, which is in the public domain.
  3. 1 2 Heist RS, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, et al. (April 2024). "Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan". Cancer Treatment Reviews. 125: 102720. doi:10.1016/j.ctrv.2024.102720. PMID 38502995.
  4. 1 2 Gadaleta-Caldarola G, Lanotte L, Infusino S, Gadaleta-Caldarola A, Schipilliti FM, Citrigno C, et al. (2023). "Safety evaluation of Datopotamab deruxtecan for triple-negative breast cancer: a meta-analysis". Cancer Treatment and Research Communications. 37: 100775. doi:10.1016/j.ctarc.2023.100775. PMID 37956525.
  5. ↑ "Datroway Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer". Daiichi Sankyo US (Press release). 17 January 2025. Retrieved 19 January 2025.
  6. ↑ "Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer". AstraZeneca US (Press release). 9 December 2024. Retrieved 20 January 2025.
  7. 1 2 "Datroway EPAR". European Medicines Agency (EMA). 30 January 2025. Retrieved 16 February 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
  9. ↑ "Datopotamab deruxtecan". American Medical Association. Retrieved 20 January 2025.
  • "Datopotamab Deruxtecan (Code C151967)". NCI Thesaurus.
  • Clinical trial number NCT05104866 for "A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)" at ClinicalTrials.gov
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