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Padcev(enfortumab vedotin)
Padcev (enfortumab vedotin) is an antibody 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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
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
Padcevenfortumab vedotin-ejfvAstellas Pharma US, Inc.N-761137 RX2019-12-18
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
padcevBiologic Licensing Application2021-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary bladder neoplasms—D001749C67
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX13: Enfortumab vedotin
HCPCS
Code
Description
J9177
Injection, enfortumab vedotin-ejfv, 0.25 mg
Clinical
Clinical Trials
30 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
Urinary bladder neoplasmsD001749C67644——12
Ureteral neoplasmsD014516EFO_0003844C66221——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic neoplasmsD014571C64-C6865———9
NeoplasmsD009369C8022———4
Urethral neoplasmsD014523EFO_000384622———3
Transitional cell carcinomaD00229522———3
Pelvic neoplasmsD01038622———3
Castration-resistant prostatic neoplasmsD064129—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Medical sociologyD0129621————1
Carcinoma in situD002278D09.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameENFORTUMAB VEDOTIN
INNenfortumab vedotin
Description
Enfortumab vedotin (human mab)
Classification
Antibody
Drug classsynthetic analogs of the dolastatin series; monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1346452-25-2
RxCUI—
ChEMBL IDCHEMBL3301589
ChEBI ID—
PubChem CID—
DrugBankDB13007
UNII IDDLE8519RWM (ChemIDplus, GSRS)
Target
Agency Approved
NECTIN4
NECTIN4
Organism
Homo sapiens
Gene name
NECTIN4
Gene synonyms
LNIR, PRR4, PVRL4
NCBI Gene ID
81607
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
Q96NY8
Mouse ortholog
Nectin4 (71740)
nectin-4 (Q8R007)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Padcev - Seagen Inc.
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 663 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,568 adverse events reported
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