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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 Application2025-12-23
herceptinBiologic Licensing Application2024-11-18
herceptin hylectaBiologic Licensing Application2025-12-10
hercessiBiologic Licensing Application2025-03-21
herzumaBiologic Licensing Application2025-12-22
kadcylaBiologic Licensing Application2025-11-21
kanjintiBiologic Licensing Application2026-03-10
ogivriBiologic Licensing Application2024-11-30
ontruzantBiologic Licensing Application2025-03-11
ontruzant ontruzantBiologic Licensing Application2024-03-01
Show 3 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
gastrointestinal neoplasms—D005770C26.9
extravasation of diagnostic and therapeutic materials—D005119—
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
1703 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_0003869C50255626196202041178
NeoplasmsD009369—C80827414329178
Stomach neoplasmsD013274EFO_0003897C16357017118121
Neoplasm metastasisD009362EFO_0009708—456512110117
Brain neoplasmsD001932EFO_0003833C71163221648
Male breast neoplasmsD018567——163021548
CardiotoxicityD066126EFO_1001482—15532438
Heart failureD006333EFO_0003144I5034—1310
Breast diseasesD001941—N60-N652531110
Second primary neoplasmsD016609———21115
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——11409—858
Colorectal neoplasmsD015179——14333—446
Non-small-cell lung carcinomaD002289——20282—445
Triple negative breast neoplasmsD064726——14231—135
Esophageal neoplasmsD004938—C159163—328
Endometrial neoplasmsD016889EFO_0004230—14104—224
Lung neoplasmsD008175—C34.9011141—424
Ovarian neoplasmsD010051EFO_0003893C5611122—323
Pancreatic neoplasmsD010190EFO_0003860C2512111—221
CarcinomaD002277—C80.08134——21
Show 28 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic neoplasmsD014571—C64-C68111———12
Renal cell carcinomaD002292EFO_0000376—47——111
Rectal neoplasmsD012004——29———11
CholangiocarcinomaD018281—C22.149———11
Transitional cell carcinomaD002295——29———11
Gastrointestinal neoplasmsD005770—C26.954——29
Uterine cervical neoplasmsD002583——55——29
Head and neck neoplasmsD006258——44——18
Liver neoplasmsD008113EFO_1001513C22.053——18
SarcomaD012509——34——38
Show 78 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———18———220
Anus neoplasmsD001005EFO_0003835C212———13
Testicular neoplasmsD013736—C622———13
Vaginal neoplasmsD014625—C522———13
Vulvar neoplasmsD014846—C512———13
Ventricular dysfunctionD018754——1———23
Hodgkin diseaseD006689—C812————2
Carcinoid tumorD002276—D3A.002————2
InsulinomaD007340——2————2
Anaplastic thyroid carcinomaD065646——2————2
Show 47 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I98————66
Intestinal diseasesD007410—K63.9————33
Intestinal polypsD007417EFO_0003855—————22
Intestinal obstructionD007415—K56.60————22
Drug therapyD004358——————22
Peripheral nervous system diseasesD010523—G64————22
Inflammatory bowel diseasesD015212EFO_0003767—————22
ObservationD019370——————11
Prospective studiesD011446——————11
Cognitive dysfunctionD060825—G31.84————11
Show 27 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
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
No data
Financial
Revenue by drug
$
€
£
₣
Herceptin – Halozyme Therapeutics
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Herceptin – Roche
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Phesgo – Roche
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Ontruzant – Organon
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Enhertu – AstraZeneca
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Trazimera – Pfizer
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Kadcyla – Immunogen
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Kadcyla – 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 9,999 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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83,435 adverse events reported
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