Kadcyla(trastuzumab emtansine)
Kadcyla (trastuzumab emtansine) is an antibody pharmaceutical. Trastuzumab emtansine was first approved as Kadcyla on 2013-02-22. It has been approved in Europe to treat breast neoplasms.
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Trade Name
FDA
EMA
Kadcyla
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 emtansine
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Kadcyla | ado-trastuzumab emtansine | Genentech | N-125427 RX | 2013-02-22 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kadcyla | Biologic Licensing Application | 2020-10-08 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9354 | Injection, ado-trastuzumab emtansine, 1 mg |
Clinical
Clinical Trials
113 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 | 28 | 45 | 19 | 1 | 5 | 86 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | 6 | — | — | 1 | 8 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 4 | — | — | — | 5 | ||
| Triple negative breast neoplasms | D064726 | 2 | 2 | — | — | — | 4 | ||
| Colorectal neoplasms | D015179 | 1 | 4 | — | — | — | 4 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 4 | — | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 2 | — | — | — | 3 |
| Multiple myeloma | D009101 | C90.0 | 1 | 2 | — | — | — | 3 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 3 | — | — | — | 3 |
| Urinary bladder neoplasms | D001749 | C67 | — | 3 | — | — | — | 3 | |
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 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 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TRASTUZUMAB EMTANSINE |
| INN | trastuzumab emtansine |
| Description | Trastuzumab Emtansine (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies; maytansinoid derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1018448-65-1 |
| RxCUI | 1371041 |
| ChEMBL ID | CHEMBL1743082 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05773 |
| UNII ID | SE2KH7T06F (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kadcyla - Immunogen
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Kadcyla - Roche
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,131 documents
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Safety
Black-box Warning
Black-box warning for: Kadcyla
Adverse Events
Top Adverse Reactions
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959 adverse events reported
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