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Enhertu(trastuzumab deruxtecan)
Enhertu (trastuzumab deruxtecan) is an antibody 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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
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
Enhertufam-trastuzumab deruxtecan-nxkiDaiichi PharmaceuticalN-761139 RX2019-12-20
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
enhertuBiologic Licensing Application2021-01-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
gastrointestinal neoplasms—D005770C26.9
Agency Specific
FDA
EMA
Expiration
Code
trastuzumab deruxtecan, Enhertu, Daiichi Sankyo, Inc
2028-01-15Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FD: Her2 (human epidermal growth factor receptor 2) inhibitors
— L01FD04: Trastuzumab deruxtecan
HCPCS
Code
Description
J9358
Injection, fam-trastuzumab deruxtecan-nxki, 1 mg
Clinical
Clinical Trials
62 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 neoplasmsD001943EFO_0003869C508981126
NeoplasmsD009369C8012—1—4
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289441——8
Stomach neoplasmsD013274EFO_0003897C16211——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517923———4
Triple negative breast neoplasmsD06472622———2
Neoplasm metastasisD009362EFO_000970811———2
AdenocarcinomaD000230—2———2
Gastrointestinal neoplasmsD005770C26.9—1———1
OsteosarcomaD012516—1———1
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
Brain neoplasmsD001932EFO_0003833C71—1———1
Esophageal neoplasmsD004938C15—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic neoplasmsD014571C64-C681————1
Salivary gland neoplasmsD012468EFO_0003826D111————1
Endometrial neoplasmsD016889EFO_00042301————1
Colonic neoplasmsD003110C181————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTRASTUZUMAB DERUXTECAN
INNtrastuzumab 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 classmonoclonal antibodies; antineoplastics (camptothecin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1826843-81-5
RxCUI—
ChEMBL IDCHEMBL4297844
ChEBI ID—
PubChem CID—
DrugBankDB14962
UNII ID5384HK7574 (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
2064
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
P04626
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Variants
Clinical Variant
No data
Financial
Enhertu - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,830 documents
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Safety
Black-box Warning
Black-box warning for: Enhertu
Adverse Events
Top Adverse Reactions
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44,805 adverse events reported
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