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| Stem definition | Drug id | CAS RN |
|---|---|---|
| antitumor, monoclonal antibodies | 5762 | None |
| Molecule | Description |
|---|---|
|
Synonyms:
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Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 4, 2025 | EMA | Daiichi Sankyo Europe GmbH | |
| Jan. 1, 2025 | FDA | Daiichi Sankyo (AstraZeneca) | |
| Dec. 12, 2024 | PMDA | Daiichi Sankyo Company, Limited |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Disease progression | 305.36 | 74.79 | 80 | 338 | 156535 | 90471494 |
| Stomatitis | 157.28 | 74.79 | 55 | 363 | 274643 | 90353386 |
| No adverse event | 85.53 | 74.79 | 25 | 393 | 67957 | 90560072 |
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| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Disease progression | 234.36 | 79.09 | 64 | 245 | 243970 | 110345020 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX35 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D018796 | Immunoconjugates |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Metastatic hormone receptor-positive cancer; HER2-negative breast cancer | indication | 417181009 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Tumor-associated calcium signal transducer 2 | Tumour-associated antigen | BINDING AGENT | EC50 | 9.13 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 2238831-60-0 | SECONDARY_CAS_RN |
| CHEMBL4297939 | ChEMBL_ID |
| C000731951 | MESH_SUPPLEMENTAL_RECORD_UI |
| 13304 | IUPHAR_LIGAND_ID |
| DB16410 | DRUGBANK_ID |
| 4043693 | VANDF |
| C5432272 | UMLSCUI |
| CHEBI:757370 | CHEBI |
| 11218 | INN_ID |
| D12359 | KEGG_DRUG |
| 392118 | MMSL |
| 43685 | MMSL |
| d10252 | MMSL |
| 019980 | NDDF |
| GD2OWY1DTK | UNII |
| 2703033 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DATROWAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65597-801 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | BLA | 32 sections |