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
Trade Name
FDA
EMA
Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera
CombinationsHerceptin 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 |
---|---|---|---|---|---|
Phesgo | pertuzumab, trastuzumab, and hyaluronidase-zzxf | Genentech | N-761170 RX | 2020-06-29 | 2 products |
Trastuzumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Herceptin | trastuzumab | Genentech | N-103792 RX | 2017-02-10 | 1 products |
Show 1 discontinued
Hyaluronidase
+
Trastuzumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Herceptin Hylecta | trastuzumab and hyaluronidase-oysk | Genentech | N-761106 RX | 2019-02-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
herceptin | Biologic Licensing Application | 2020-10-19 |
herzuma | Biologic Licensing Application | 2020-03-19 |
kadcyla | Biologic Licensing Application | 2023-06-06 |
kanjinti | Biologic Licensing Application | 2019-10-25 |
ogivri | Biologic Licensing Application | 2021-02-08 |
ontruzant ontruzant | Biologic Licensing Application | 2023-01-31 |
phesgo | Biologic Licensing Application | 2020-06-29 |
trazimera | Biologic Licensing Application | 2021-03-10 |
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, Herceptin, Genentech, Inc. | |||
2117-10-20 | Orphan 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 neoplasms | D001943 | EFO_0003869 | C50 | 169 | 395 | 138 | 12 | 46 | 683 |
Neoplasms | D009369 | C80 | 34 | 32 | 5 | 1 | 8 | 73 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 15 | 38 | 11 | 1 | 5 | 61 |
Male breast neoplasms | D018567 | 9 | 11 | 2 | 1 | — | 20 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-small-cell lung carcinoma | D002289 | 10 | 14 | 1 | — | 1 | 23 | ||
Colorectal neoplasms | D015179 | 7 | 16 | 1 | — | 1 | 21 | ||
Adenocarcinoma | D000230 | 3 | 17 | 2 | — | 2 | 20 | ||
Brain neoplasms | D001932 | EFO_0003833 | C71 | 7 | 13 | 1 | — | — | 17 |
Triple negative breast neoplasms | D064726 | 8 | 11 | 1 | — | — | 16 | ||
Esophageal neoplasms | D004938 | C15 | 7 | 10 | 2 | — | — | 16 | |
Neoplasm metastasis | D009362 | EFO_0009708 | 4 | 8 | 1 | — | — | 11 | |
Inflammatory breast neoplasms | D058922 | 3 | 4 | 3 | — | — | 9 | ||
Invasive hydatidiform mole | D002820 | D39.2 | 3 | 5 | 1 | — | — | 8 | |
Biliary tract neoplasms | D001661 | C24.9 | — | 5 | 1 | — | — | 6 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 8 | 8 | — | — | — | 14 |
Urinary bladder neoplasms | D001749 | C67 | 4 | 9 | — | — | — | 11 | |
Endometrial neoplasms | D016889 | EFO_0004230 | 8 | 5 | — | — | — | 10 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 5 | 5 | — | — | 1 | 10 |
Lung neoplasms | D008175 | C34.90 | 4 | 8 | — | — | 1 | 10 | |
Prostatic neoplasms | D011471 | C61 | 2 | 4 | — | — | 1 | 7 | |
Multiple myeloma | D009101 | C90.0 | 2 | 5 | — | — | — | 6 | |
Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 2 | 4 | — | — | — | 6 |
Rectal neoplasms | D012004 | 1 | 5 | — | — | — | 6 | ||
Urologic neoplasms | D014571 | C64-C68 | 1 | 5 | — | — | — | 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 disease | D006689 | C81 | 2 | — | — | — | — | 2 | |
Ovarian epithelial carcinoma | D000077216 | 2 | — | — | — | — | 2 | ||
Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
Show 28 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TRASTUZUMAB |
INN | trastuzumab |
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 class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | >5U6A:A|Light Chain
DIQMTQSPILLSASVGDRVTITCRASQDVNTAVAWYQQRTNGSPRLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQP
EDEADYYCQQHYTTPPTFGAGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>5U6A:B|Heavy Chain
EVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQSPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAY
LQMNSLRAEDTAIYYCSRWGGDGFYAMDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS
WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSC |
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
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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