enfortumab vedotin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
human origin 5366 1346452-25-2

Description:

MoleculeDescription

Synonyms:

  • enfortumab
  • enfortumab vedotin
  • enfortumab-vedotin-ejfv
  • padcev
  • AGS-22CE
  • AGS-22ME
  • AGS-22M6E
  • enfortumab vedotin (genetical recombination)
Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 directed against Nectin-4, an adhesion protein located on the surface of cells. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic cell death.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 18, 2019 FDA ASTELLAS
Sept. 27, 2021 PMDA ASTELLAS PHARMA INC.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Neuropathy peripheral 106.37 41.36 47 755 70980 29502745
Rash 104.68 41.36 64 738 189755 29383970
Hyperglycaemia 48.81 41.36 22 780 34265 29539460

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Neuropathy peripheral 84.44 44.92 35 637 117490 64380570
Rash 59.65 44.92 44 628 458505 64039555
Hyperglycaemia 53.41 44.92 21 651 60947 64437113

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX13 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Metastatic urothelial carcinoma indication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tubulin beta Tumour-associated antigen BINDING AGENT UNKNOWN DRUG LABEL
Nectin-4 Tumour-associated antigen BINDING AGENT Ki 10.24 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
CHEMBL3301589 ChEMBL_ID
D11525 KEGG_DRUG
C000632577 MESH_SUPPLEMENTAL_RECORD_UI
10738 IUPHAR_LIGAND_ID
9821 INN_ID
1448664-46-7 SECONDARY_CAS_RN
DB13007 DRUGBANK_ID
DLE8519RWM UNII
2268093 RXNORM
328359 MMSL
37850 MMSL
37854 MMSL
d09466 MMSL
836465002 SNOMEDCT_US
838468009 SNOMEDCT_US
4039044 VANDF
C4519740 UMLSCUI
CHEMBL3301579 ChEMBL_ID
018235 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PADCEVEJFV HUMAN PRESCRIPTION DRUG LABEL 1 51144-020 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 20 mg INTRAVENOUS BLA 31 sections
PADCEVEJFV HUMAN PRESCRIPTION DRUG LABEL 1 51144-030 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 30 mg INTRAVENOUS BLA 31 sections