This promotional website is intended for EU Healthcare Professionals only.

DATROWAY is a specifically engineered TROP-2-directed antibody-drug conjugate (ADC)1,13

Designed to induce selective tumor cell death and reduce systemic exposure to the topoisomerase I inhibitor payload1,13,a

DNA=deoxyribonucleic acid; mAb=monoclonal antibody.
aInformation from laboratory studies suggests that this is how DATROWAY works. The clinical relevance of these features is under investigation.13

Abbreviations

2L+, second line or later
5-HT3, 5-hydroxytryptamine type 3
ADC, antibody-drug conjugate
ALT, alanine aminotransferase
ARs, adverse reactions
AST, aspartate aminotransferase
BICR, blinded independent central review
CDK, cyclin-dependant kinases
CI, confidence interval
CR, complete response
Dato-DXd, datopotamab deruxtecan
DCR, disease control rate
DNA, deoxyribonucleic acid
DoR, duration of response
ECOG PS, Eastern Cooperative Oncology Group Performance Status
ET, endocrine therapy
G-CSF, granulocyte-colony stimulating factor
HER2-, human epidermal growth factor receptor 2-negative
HR+, hormone receptor-positive
HR, hazard ratio
ICC, investigator’s choice of chemotherapy
IHC, immunohistochemistry
ISH, in situ hybridization
IV, intravenous
mAb, monoclonal antibody
mBC, metastic breast cancer
mPFS, median progression-free survival
ORR, objective response rate
OS, overall survival
PFS, progression-free survival
PR, partial response
Q3W, once every 3 weeks
RECIST, Response Evaluation Criteria in Solid Tumors
SD, stable disease
TRAEs, treatment-related adverse events
TROP-2, trophoblast cell-surface antigen 2

References

  1.  DATROWAY SUMMARY OF PRODUCT CHARACTERISTICS, European Medicine Agency: EPAR - Product information, First Published: April/2025. Available at https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf accessed in April 2026. Daiichi-Sankyo Europe GmbH and AstraZeneca
  2. Bardia A, Jhaveri K, Im SA, et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer: Primary results from the randomized phase 3 TROPION-Breast01 trial. Presented at: European Society for Medical Oncology Congress 2023; October 20–24, 2023; Madrid, Spain.
  3. Pistilli B. et al., Feb 2025; ESMO virtual plenary: Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer.
  4. Jhaveri K, Bardia A, Im SA, et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in pretreated, inoperable/metastatic HR+/HER2– breast cancer: Additional safety analysis from TROPION-Breast01. Presented at: European Society for Medical Oncology Congress 2024; October 20–24, 2024; Madrid, Spain.
  5. Robins JM. Proceedings of the Biopharmaceutical Section (American Statisical Association) 1993; 24-33.
  6. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. National Cancer Institute; 2017
  7. Robins JM, Finkelstein DM. Blometries 2000; 56:779-88;
  8. Sherry AD, et al. EMJ Oncology 2024; 3.e000322.
  9. Heist RS, Sands J, Bardia A, et al. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treat Rev. 2024;125:102720.
  10. Bardia A, Jhaveri K, Im SA, et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: primary results from TROPION-Breast01. J Clin Oncol. Published online September 12, 2024. doi:10.1200/JCO.24.00920.
  11. Peterson DE, Boers-Doets CB, Bensadoun RJ, Herrstedt J; ESMO Guidelines Committee. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Ann Oncol. 2015;26 Suppl 5:v139-v151. doi:10.1093/annonc/mdv202.
  12. Nelson BE, Meric-Bernstam F. Leveraging TROP2 antibody-drug conjugates in solid tumors. Annu Rev Med. 2024;75:31-48. doi:10.1146/annurevmed- 071322-065903.
  13. Okajima D, Yasuda S, Maejima T, et al. Datopotamab deruxtecan, a novel TROP2-directed antibody-drug conjugate, demonstrates potent antitumor activity by efficient drug delivery to tumor cells. Mol Cancer Ther. 2021;20(12):2329-2340. doi:10.1158/1535-7163.MCT-21-0206.
  14. Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.). SKB264 injection vs investigator selected regimens to treat locally advanced, recurrent or metastatic triple-negative breast cancer. ClinicalTrials.gov Identifier: NCT05347134. Updated October 23, 2023. Accessed April 2026. https://www.clinicaltrials.gov/study/NCT05347134.
  15. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res. 2016;22(20):5097-5108. doi:10.1158/1078-0432.CCR-15-2822.
  16. Bardia A, Jhaveri K, Kalinsky K, et al. TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2− breast cancer. Future Oncol. 2024;20(8):423-436. doi:10.2217/fon-2023-0188
  17. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402(10411):1423-1433. doi:10.1016/S0140- 6736(23)01245-X.

Please see additional Important Safety Information throughout,  and accompanying full Prescribing Information, including Warnings and Precautions, and Medication Guide.

[dc-login]