Datopotamab deruxtecan
Datroway (datopotamab deruxtecan) is an antibody drug conjugate pharmaceutical. Datopotamab deruxtecan was first approved as Datroway on 2025-01-17.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Datroway
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Datopotamab deruxtecan
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Datroway | datopotamab deruxtecan-dlnk | Daiichi Pharmaceutical | N-761394 RX | 2025-01-17 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| datroway | Biologic Licensing Application | 2025-07-10 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
40 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 6 | 9 | 8 | — | 1 | 22 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 12 | 5 | — | — | 18 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 8 | 2 | — | 1 | 11 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 2 | 3 | — | — | 5 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 2 | 1 | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | — | — | 1 | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 4 | 9 | — | — | — | 10 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 4 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 3 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 2 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 2 | — | — | — | 2 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Datopotamab deruxtecan |
| INN | datopotamab deruxtecan |
| Description | Ds-1062 is an unknown pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Unknown |
| Drug class | monoclonal antibodies; antineoplastics (camptothecin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297939 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16410 |
| UNII ID | GD2OWY1DTK (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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115 adverse events reported
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