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| <!-- Identifiers --> | <!-- Identifiers --> | ||
| | CAS_number = | | CAS_number = 2238831-60-0 | ||
| | CAS_supplemental = | | CAS_supplemental = | ||
| | PubChem = | | PubChem = | ||
| | IUPHAR_ligand = | | IUPHAR_ligand = | ||
| | DrugBank = | | DrugBank = DB16410 | ||
| | ChemSpiderID = | | ChemSpiderID = | ||
| | UNII = | | UNII = GD2OWY1DTK | ||
| | KEGG = | | KEGG = D12359 | ||
| | ChEBI = | | ChEBI = | ||
| | ChEMBL = | | ChEMBL = | ||
| | NIAID_ChemDB = | | NIAID_ChemDB = | ||
| | PDB_ligand = | | PDB_ligand = | ||
| | synonyms = datopotamab deruxtecan-dlnk | | synonyms = DS-1062, datopotamab deruxtecan-dlnk | ||
| <!-- Chemical and physical data --> | <!-- Chemical and physical data --> | ||
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| }} | }} | ||
| '''Datopotamab deruxtecan''', sold under the brand name '''Datroway''', is an ] used for the treatment of ].<ref name="Datroway FDA label" /><ref name="FDA 20250117" /> It is a Trop-2-directed antibody and topoisomerase inhibitor conjugate.<ref name="Datroway FDA label" /><ref name="FDA 20250117" /> |
'''Datopotamab deruxtecan''' (Dato-DXd),<ref>{{cite journal | vauthors = ((World Health Organization)) | year = 2020 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84 | journal = WHO Drug Information | volume = 34 | issue = 3 | hdl = 10665/340680 | hdl-access = free | author-link = World Health Organization }}</ref> sold under the brand name '''Datroway''', is an ] used for the treatment of ].<ref name="Datroway FDA label" /><ref name="FDA 20250117" /> It is a ]-directed antibody and ] inhibitor ].<ref name="Datroway FDA label" /><ref name="FDA 20250117" /><ref name="Datroway FDA label" /> | ||
| 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.<ref name="FDA 20250117" /> | 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.<ref name="FDA 20250117" /> | ||
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| == Medical uses == | == Medical uses == | ||
| Datopotamab deruxtecan is ] for adults with unresectable or metastatic, ], 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.<ref name="FDA 20250117" /> | Datopotamab deruxtecan is ] for the treatment of adults with unresectable or metastatic, ], 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.<ref name="FDA 20250117" /> | ||
| == Side effects == | |||
| While demonstrating encouraging antitumor activity, Dato-DXd is associated with a range of adverse events that require careful management.<ref name="Heist_2024">{{cite journal | vauthors = Heist RS, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung SS, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F | title = Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan | journal = Cancer Treatment Reviews | volume = 125 | issue = | pages = 102720 | date = April 2024 | pmid = 38502995 | doi = 10.1016/j.ctrv.2024.102720 }}</ref><ref name="Gadaleta-Caldarola_2023">{{cite journal | vauthors = Gadaleta-Caldarola G, Lanotte L, Infusino S, Gadaleta-Caldarola A, Schipilliti FM, Citrigno C, Petrarota C, Cusmai A, Rizzo A | title = Safety evaluation of Datopotamab deruxtecan for triple-negative breast cancer: a meta-analysis | journal = Cancer Treatment and Research Communications | volume = 37 | issue = | pages = 100775 | date = 2023 | pmid = 37956525 | doi = 10.1016/j.ctarc.2023.100775 }}</ref> ] is the most common severe event (13.88%).<ref name="Gadaleta-Caldarola_2023" /> Other side effect include ], infusion-related reactions, oral ], and ocular surface events.<ref name="Heist_2024" /> | |||
| == History == | == History == | ||
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| == External links == | == External links == | ||
| * {{cite web | title=Datopotamab Deruxtecan (Code C151967) | website=NCI Thesaurus | url=https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C151967 }} | |||
| * {{ClinicalTrialsGov|NCT05104866|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)}} | * {{ClinicalTrialsGov|NCT05104866|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)}} | ||
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| {{Portal bar | Medicine}} | {{Portal bar | Medicine}} | ||
| {{Authority control}} | {{Authority control}} | ||
Latest revision as of 09:23, 19 January 2025
MedicationPharmaceutical compound
| Clinical data | |
|---|---|
| Trade names | Datroway |
| Other names | DS-1062, datopotamab deruxtecan-dlnk |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Datopotamab deruxtecan (Dato-DXd), sold under the brand name Datroway, is an anti-cancer medication used for the treatment of breast cancer. It is a Trop-2-directed antibody and topoisomerase inhibitor antibody-drug conjugate.
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.
Datopotamab deruxtecan was approved for medical use in the United States in January 2025.
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.
Side effects
While demonstrating encouraging antitumor activity, Dato-DXd is associated with a range of adverse events that require careful management. stomatitis is the most common severe event (13.88%). Other side effect include pneumonitis, infusion-related reactions, oral mucositis, and ocular surface events.
History
Efficacy was evaluated in TROPION-Breast01 (NCT05104866), a multicenter, open-label, randomized trial. 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. Participants were excluded for a history of ILD/pneumonitis requiring steroids, ongoing ILD/pneumonitis, clinically active brain metastases, or clinically significant corneal disease. Participants also were excluded for ECOG performance status >1. Randomization was stratified by previous lines of chemotherapy, prior CDK4/6 inhibitor treatment, and geographical region. 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%).
References
- ^ https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf
- World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
- ^ "FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer". U.S. Food and Drug Administration. 17 January 2025. Retrieved 19 January 2025.
This article incorporates text from this source, which is in the public domain.
- "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.
- ^ 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.
- ^ 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.
External links
- "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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