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Drug ReportsTrastuzumab
Herceptin(trastuzumab)
Herceptin, Hercessi, Herwenda, Herzuma, Kanjinti, Ogivri, Ontruzant, Phesgo, Trazimera, Zercepac (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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Herceptin, Hercessi, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera (discontinued: Herceptin)
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)
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
Hyaluronidase
+
Pertuzumab
+
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentechN-761170 RX2020-06-29
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
enhertuBiologic Licensing Application2025-01-28
herceptinBiologic Licensing Application2024-11-18
herceptin hylectaBiologic Licensing Application2024-11-21
hercessiBiologic Licensing Application2025-03-21
herzumaBiologic Licensing Application2025-02-12
kadcylaBiologic Licensing Application2024-11-18
kanjintiBiologic Licensing Application2024-12-20
ogivriBiologic Licensing Application2024-11-30
ontruzantBiologic Licensing Application2025-03-11
ontruzant ontruzantBiologic Licensing Application2024-03-01
Show 3 more
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
1547 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_0003869C50247607208181891152
NeoplasmsD009369C80867410326176
Stomach neoplasmsD013274EFO_0003897C16307117216118
Neoplasm metastasisD009362EFO_00097082543101879
CardiotoxicityD066126EFO_100148216612437
Male breast neoplasmsD018567112021434
Heart failureD006333EFO_0003144I50341310
Breast diseasesD001941N60-N65252119
Second primary neoplasmsD016609141129
Liver neoplasmsD008113EFO_1001513C22.034118
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230144712972
CarcinomaD002277C80.020317153
Brain neoplasmsD001932EFO_0003833C7110332546
Esophageal neoplasmsD004938C1513256239
Colorectal neoplasmsD01517911283237
Non-small-cell lung carcinomaD00228912232335
Lung neoplasmsD008175C34.9014223335
RecurrenceD01200811125126
Triple negative breast neoplasmsD064726916123
Ovarian neoplasmsD010051EFO_0003893C5610112119
Show 28 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic neoplasmsD014571C64-C681910
Gastrointestinal neoplasmsD005770C26.93519
Transitional cell carcinomaD002295279
Multiple myelomaD009101C90.03518
Renal cell carcinomaD002292EFO_0000376368
CholangiocarcinomaD018281C22.1278
Squamous cell carcinomaD002294368
SarcomaD0125093528
MelanomaD008545467
Left ventricular dysfunctionD0184871337
Show 82 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients16218
Hodgkin diseaseD006689C8122
Carcinoid tumorD002276D3A.0022
EpendymomaD00480622
Myelodysplastic syndromesD009190D4611
Myeloid leukemia acuteD015470C92.011
Primary myelofibrosisD055728D47.411
B-cell chronic lymphocytic leukemiaD015451C91.111
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
Myelomonocytic leukemia chronicD015477C93.111
Show 47 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I9855
Intestinal diseasesD007410K63.944
Intestinal polypsD007417EFO_000385522
Intestinal obstructionD007415K56.6022
Drug therapyD00435822
Inflammatory bowel diseasesD015212EFO_000376722
ObservationD01937011
Prospective studiesD01144611
Chemotherapy-related cognitive impairmentD00008420211
FatigueD005221R53.8311
Show 21 more
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)Loading
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-ID
RxCUI
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
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Ontruzant Organon
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Trazimera Pfizer
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Herceptin Halozyme Therapeutics
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Herceptin Roche
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Phesgo Roche
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 67,948 documents
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Safety
Black-box Warning
Black-box warning for: Enhertu, Herceptin, Herceptin hylecta, Hercessi, Herzuma, Kadcyla, Kanjinti, Ogivri, Ontruzant, Ontruzant ontruzant, Phesgo, Trazimera, Trazimera-qyyp
Adverse Events
Top Adverse Reactions
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72,645 adverse events reported
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