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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Target
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Events Timeline
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YTD
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5Y
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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
Trade Name
FDA
EMA
Herceptin, Hercessi, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera (discontinued: Herceptin)
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)
Trastuzumab
Hyaluronidase
+
Trastuzumab
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enhertu | Biologic Licensing Application | 2024-04-10 |
| herceptin | Biologic Licensing Application | 2024-11-18 |
| herceptin hylecta | Biologic Licensing Application | 2024-11-21 |
| hercessi | Biologic Licensing Application | 2024-09-19 |
| herzuma | Biologic Licensing Application | 2024-11-25 |
| kadcyla | Biologic Licensing Application | 2024-11-18 |
| kanjinti | Biologic Licensing Application | 2024-03-22 |
| ogivri | Biologic Licensing Application | 2024-11-30 |
| ontruzant ontruzant | Biologic Licensing Application | 2024-03-01 |
| phesgo | Biologic Licensing Application | 2024-12-02 |
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Indications
FDA
EMA
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
1512 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary tract neoplasms | D001661 | — | C24.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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
No data
Financial
Revenue by drug
$
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Phesgo – Roche
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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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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 63,724 documents
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Safety
Black-box Warning
Black-box warning for: Enhertu, Herceptin, Herceptin hylecta, Hercessi, Herzuma, Kadcyla, Kanjinti, Ogivri, Ontruzant ontruzant, Phesgo, Trazimera, Trazimera-qyyp
Adverse Events
Top Adverse Reactions
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74,221 adverse events reported
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