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Herceptin(trastuzumab)
Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Phesgo, Trazimera (trastuzumab) is an antibody pharmaceutical. Trastuzumab was first approved as Herceptin on 1998-09-25. It is used to treat breast neoplasms and gastrointestinal neoplasms in the USA. It has been approved in Europe to treat breast neoplasms and stomach neoplasms. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera
Combinations
Herceptin hylecta, Phesgo
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)
Hyaluronidase
+
Pertuzumab
+
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentechN-761170 RX2020-06-29
2 products
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
HerceptintrastuzumabGenentechN-103792 RX2017-02-10
1 products
Show 1 discontinued
Hyaluronidase
+
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
Herceptin Hylectatrastuzumab and hyaluronidase-oyskGenentechN-761106 RX2019-02-28
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
herceptinBiologic Licensing Application2020-10-19
herzumaBiologic Licensing Application2020-03-19
kadcylaBiologic Licensing Application2023-06-06
kanjintiBiologic Licensing Application2019-10-25
ogivriBiologic Licensing Application2021-02-08
ontruzant ontruzant Biologic Licensing Application2023-01-31
phesgoBiologic Licensing Application2020-06-29
trazimeraBiologic Licensing Application2021-03-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
gastrointestinal neoplasms—D005770C26.9
Agency Specific
FDA
EMA
Expiration
Code
trastuzumab, Herceptin, Genentech, Inc.
2117-10-20Orphan 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
— L01FD01: Trastuzumab
— L01FD03: Trastuzumab emtansine
— L01FD04: Trastuzumab deruxtecan
— L01FD05: Trastuzumab duocarmazine
— L01X: Other antineoplastic agents in atc
— L01XY: Combinations of antineoplastic agents
— L01XY02: Pertuzumab and trastuzumab
HCPCS
Code
Description
J9316
Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per 10 mg
J9354
Injection, ado-trastuzumab emtansine, 1 mg
J9355
Injection, trastuzumab, excludes biosimilar, 10 mg
J9356
Injection, trastuzumab, 10 mg and hyaluronidase-oysk
J9358
Injection, fam-trastuzumab deruxtecan-nxki, 1 mg
Q5112
Injection, trastuzumab-dttb, biosimilar, (ontruzant), 10 mg
Q5113
Injection, trastuzumab-pkrb, biosimilar, (herzuma), 10 mg
Q5114
Injection, trastuzumab-dkst, biosimilar, (ogivri), 10 mg
Q5116
Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg
Q5117
Injection, trastuzumab-anns, biosimilar, (kanjinti), 10 mg
Clinical
Clinical Trials
1000 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_0003869C501693951381246683
NeoplasmsD009369C80343251873
Stomach neoplasmsD013274EFO_0003897C161538111561
Male breast neoplasmsD01856791121—20
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228910141—123
Colorectal neoplasmsD0151797161—121
AdenocarcinomaD0002303172—220
Brain neoplasmsD001932EFO_0003833C717131——17
Triple negative breast neoplasmsD0647268111——16
Esophageal neoplasmsD004938C157102——16
Neoplasm metastasisD009362EFO_0009708481——11
Inflammatory breast neoplasmsD058922343——9
Invasive hydatidiform moleD002820D39.2351——8
Biliary tract neoplasmsD001661C24.9—51——6
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C2588———14
Urinary bladder neoplasmsD001749C6749———11
Endometrial neoplasmsD016889EFO_000423085———10
Ovarian neoplasmsD010051EFO_0003893C5655——110
Lung neoplasmsD008175C34.9048——110
Prostatic neoplasmsD011471C6124——17
Multiple myelomaD009101C90.025———6
Salivary gland neoplasmsD012468EFO_0003826D1124———6
Rectal neoplasmsD01200415———6
Urologic neoplasmsD014571C64-C6815———6
Show 44 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—14————14
Hodgkin diseaseD006689C812————2
Ovarian epithelial carcinomaD0000772162————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Primary myelofibrosisD055728D47.41————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003401————1
Myelomonocytic leukemia chronicD015477C93.11————1
Show 28 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObservationD019370————11
FatigueD005221HP_0012378R53.83————11
PregnancyD011247EFO_0002950Z33.1————11
Second primary neoplasmsD016609————11
RecurrenceD012008————11
Intraductal carcinoma noninfiltratingD002285D05.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTRASTUZUMAB
INNtrastuzumab
Description
Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)TRASTUZUMAB
Structure (InChI/SMILES or Protein Sequence)
>5U6A:A|Light Chain DIQMTQSPILLSASVGDRVTITCRASQDVNTAVAWYQQRTNGSPRLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQP EDEADYYCQQHYTTPPTFGAGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >5U6A:B|Heavy Chain EVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQSPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAY LQMNSLRAEDTAIYYCSRWGGDGFYAMDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSC
Identifiers
PDB4HJG, 4HKZ, 4IOI, 5U3D, 5U5F, 5U5M, 5U6A, 5XHF, 5XHG, 6B9Y, 6B9Z, 6BAE, 6BAH, 6BGT, 6BHZ, 6BI0, 6BI2, 6OGE, 7MN8, 7PKL
CAS-ID180288-69-1
RxCUI224905
ChEMBL IDCHEMBL1201585
ChEBI ID—
PubChem CID—
DrugBankDB00072
UNII IDP188ANX8CK (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ontruzant - Organon
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Phesgo - Roche
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Herceptin - Halozyme Therapeutics
$
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Herceptin - Roche
$
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Trazimera - Pfizer
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 52,928 documents
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Safety
Black-box Warning
Black-box warning for: Herceptin, Herzuma, Kadcyla, Kanjinti, Ogivri, Ontruzant ontruzant , Phesgo, Trazimera
Adverse Events
Top Adverse Reactions
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15,170 adverse events reported
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