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
Trade Name
FDA
EMA
Enhertu
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
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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
103 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 | 11 | 12 | 8 | 1 | 3 | 32 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | — | 1 | — | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 5 | 1 | — | — | 9 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 3 | 1 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 3 | 4 | — | — | — | 5 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 4 | — | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | — | — | 1 | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 1 | — | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | — | 2 | — | — | — | 2 |
| Hemangiosarcoma | D006394 | — | — | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 1 | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 1 | — | — | — | 1 |
Show 11 more
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 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 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 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 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
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Enhertu – AstraZeneca
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Safety
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959 adverse events reported
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