Enhertu(trastuzumab deruxtecan)
Enhertu (trastuzumab deruxtecan) is an antibody drug conjugate pharmaceutical. Trastuzumab deruxtecan was first approved as Enhertu on 2019-12-20. It is used to treat breast neoplasms and gastrointestinal neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. It is known to target receptor tyrosine-protein kinase erbB-2.
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Commercial
Therapeutic Areas
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EMA
Enhertu
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)
Trastuzumab deruxtecan
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Enhertu | fam-trastuzumab deruxtecan-nxki | Daiichi Pharmaceutical | N-761139 RX | 2019-12-20 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enhertu | Biologic Licensing Application | 2024-04-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| gastrointestinal neoplasms | — | D005770 | C26.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
trastuzumab deruxtecan, Enhertu, Daiichi Sankyo, Inc | |||
| 2028-01-15 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9358 | Injection, fam-trastuzumab deruxtecan-nxki, 1 mg |
Clinical
Clinical Trials
124 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 21 | 36 | 12 | 3 | 14 | 78 |
| Neoplasms | D009369 | — | C80 | 14 | 8 | 1 | 1 | 5 | 25 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 5 | 2 | — | 3 | 15 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 7 | 8 | 1 | — | 1 | 13 |
| Adenocarcinoma | D000230 | — | — | 5 | 8 | 1 | — | 1 | 13 |
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 8 | 1 | — | — | 12 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 4 | 5 | 1 | — | 1 | 10 |
| Esophageal neoplasms | D004938 | — | C15 | 4 | 3 | 1 | — | 1 | 8 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 5 | 1 | — | — | 6 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 1 | 1 | — | — | 2 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 3 | 6 | — | — | 1 | 8 |
| Triple negative breast neoplasms | D064726 | — | — | 3 | 5 | — | — | — | 7 |
| Carcinoma | D002277 | — | C80.0 | 4 | 2 | — | — | — | 6 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 1 | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | — | 2 | — | — | — | 2 |
| Hemangiosarcoma | D006394 | — | — | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 1 | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | 1 | 2 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | — | — | — | 1 |
| Serous cystadenocarcinoma | D018284 | — | — | 1 | — | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | 1 | — | — | — | — | 1 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | — | — | 1 | 1 |
| Melanoma | D008545 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Trastuzumab deruxtecan |
| INN | trastuzumab deruxtecan |
| Description | Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan (a derivative of exatecan). It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma. Trastuzumab binds to and blocks signaling through epidermal growth factor receptor 2 (HER2/neu) on cancers that rely on it for growth. Additionally, once bound to HER2 receptors, the antibody is internalized by the cell, carrying the bound deruxtecan along with it, where it interferes with the cell's ability to make DNA structural changes and replicate its DNA during cell division, leading to DNA damage when the cell attempts to replicate itself, destroying the cell.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies; antineoplastics (camptothecin derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1826843-81-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297844 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14962 |
| UNII ID | 5384HK7574 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Variants
No data
Financial
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Enhertu – AstraZeneca
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Trends
PubMed Central
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Additional graphs summarizing 3,571 documents
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Safety
Black-box Warning
Black-box warning for: Enhertu
Adverse Events
Top Adverse Reactions
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5,714 adverse events reported
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