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

Stem definition	Drug id	CAS RN
human origin	5366	1346452-25-2

Description:

Molecule	Description
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

Molecule

Description

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:

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Date	Agency	Company
April 13, 2022	EMA	ASTELLAS PHARMA EUROPE B.V.
Dec. 18, 2019	FDA	ASTELLAS
Sept. 27, 2021	PMDA	ASTELLAS PHARMA INC.

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Taste disorder	74.44	58.60	18	486	13644	63474874
Malignant neoplasm progression	67.42	58.60	25	479	82096	63406422

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	193.25	36.22	107	2682	87939	34866203
Taste disorder	170.16	36.22	49	2740	7106	34947036
Rash	167.37	36.22	139	2650	222613	34731529
Neuropathy peripheral	149.84	36.22	89	2700	83174	34870968
Hyperglycaemia	123.53	36.22	61	2728	39419	34914723
Myelosuppression	122.58	36.22	49	2740	19216	34934926
Alopecia	114.75	36.22	50	2739	24305	34929837
Skin disorder	91.49	36.22	36	2753	13519	34940623
Decreased appetite	72.37	36.22	77	2712	166315	34787827
Stevens-Johnson syndrome	47.14	36.22	25	2764	18614	34935528

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Taste disorder	251.80	37.22	67	2889	15756	79725676
Malignant neoplasm progression	248.60	37.22	114	2842	135876	79605556
Myelosuppression	163.66	37.22	60	2896	40236	79701196
Neuropathy peripheral	152.59	37.22	83	2873	141222	79600210
Hyperglycaemia	121.94	37.22	57	2899	70278	79671154
Rash	118.68	37.22	125	2831	578233	79163199
Skin disorder	110.41	37.22	43	2913	33900	79707532
Decreased appetite	92.16	37.22	86	2870	342332	79399100
Alopecia	65.75	37.22	60	2896	231295	79510137
Skin toxicity	51.53	37.22	17	2939	8297	79733135

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

Disease	Relation	SNOMED_ID	DOID
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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tubulin beta	Tumour-associated antigen	P07437 Q9H4B7 Q13885 Q9BVA1 Q13509 P04350 P68371 Q9BUF5 Q3ZCM7	TBB5_HUMAN TBB1_HUMAN TBB2A_HUMAN TBB2B_HUMAN TBB3_HUMAN TBB4A_HUMAN TBB4B_HUMAN TBB6_HUMAN TBB8_HUMAN	BINDING AGENT				UNKNOWN	DRUG LABEL
Nectin-4	Tumour-associated antigen	Q96NY8	NECT4_HUMAN	BINDING AGENT	Ki	10.24		SCIENTIFIC LITERATURE	DRUG LABEL

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External reference:

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ID	Source
018235	NDDF
10738	IUPHAR_LIGAND_ID
1448664-46-7	SECONDARY_CAS_RN
2268093	RXNORM
328359	MMSL
37850	MMSL
37854	MMSL
4039044	VANDF
836465002	SNOMEDCT_US
838468009	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	51144-020	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	20 mg	INTRAVENOUS	BLA	31 sections
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
PADCEVEJFV	HUMAN PRESCRIPTION DRUG LABEL	1	51144-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	30 mg	INTRAVENOUS	BLA	31 sections
PADCEVEJFV	HUMAN PRESCRIPTION DRUG LABEL	1	51144-030	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	30 mg	INTRAVENOUS	BLA	31 sections

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