Padcev(enfortumab vedotin)
Padcev (enfortumab vedotin) is an antibody drug conjugate pharmaceutical. Enfortumab vedotin was first approved as Padcev on 2019-12-18. It is used to treat urinary bladder neoplasms in the USA. It has been approved in Europe to treat transitional cell carcinoma and urologic neoplasms. The pharmaceutical is active against nectin-4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Padcev
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)
Enfortumab vedotin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Padcev | enfortumab vedotin-ejfv | Astellas Pharma | N-761137 RX | 2019-12-18 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| padcev | Biologic Licensing Application | 2024-08-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9177 | Injection, enfortumab vedotin-ejfv, 0.25 mg |
Clinical
Clinical Trials
47 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 |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 9 | 14 | 1 | — | 2 | 22 |
| Urinary bladder neoplasms | D001749 | — | C67 | 9 | 12 | 5 | — | 1 | 21 |
| Urologic neoplasms | D014571 | — | C64-C68 | 8 | 11 | 1 | — | 1 | 16 |
| Neoplasms | D009369 | — | C80 | 3 | 6 | 1 | — | 1 | 9 |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 3 | 3 | 1 | — | — | 6 |
| Muscle neoplasms | D019042 | — | C49 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | 10 | 12 | — | — | 2 | 20 |
| Urethral neoplasms | D014523 | EFO_0003846 | — | 2 | 3 | — | — | — | 4 |
| Pelvic neoplasms | D010386 | — | — | 2 | 3 | — | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | — | 3 | — | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Medical sociology | D012962 | — | — | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | — | — | 1 | 1 |
| Eye abnormalities | D005124 | HP_0000478 | Q15.9 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Enfortumab vedotin |
| INN | enfortumab vedotin |
| Description | Enfortumab vedotin (human mab) |
| Classification | Antibody |
| Drug class | synthetic analogs of the dolastatin series; monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301589 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13007 |
| UNII ID | DLE8519RWM (ChemIDplus, GSRS) |
Target
Agency Approved
NECTIN4
NECTIN4
Organism
Homo sapiens
Gene name
NECTIN4
Gene synonyms
LNIR, PRR4, PVRL4
NCBI Gene ID
Protein name
nectin-4
Protein synonyms
Ig superfamily receptor LNIR, nectin 4, Nectin cell adhesion molecule 4, poliovirus receptor-related 4, Poliovirus receptor-related protein 4
Uniprot ID
Mouse ortholog
Nectin4 (71740)
nectin-4 (Q8R007)
Alternate
No data
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,125 documents
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Safety
Black-box Warning
Black-box warning for: Padcev
Adverse Events
Top Adverse Reactions
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2,701 adverse events reported
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