Last update 31 Jul 2025

Enfortumab Vedotin-ejfv

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Enfortumab vedotin, Enfortumab Vedotin (Genetical Recombination), 恩诺单抗
+ [15]
Action
inhibitors
Mechanism
Tubulin inhibitors, nectin-4 inhibitors(Nectin-4 inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (18 Dec 2019),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (South Korea)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Unresectable Urothelial Carcinoma
European Union
24 Sep 2024
Unresectable Urothelial Carcinoma
Iceland
24 Sep 2024
Unresectable Urothelial Carcinoma
Liechtenstein
24 Sep 2024
Unresectable Urothelial Carcinoma
Norway
24 Sep 2024
Locally Advanced Urothelial Carcinoma
European Union
13 Apr 2022
Locally Advanced Urothelial Carcinoma
Iceland
13 Apr 2022
Locally Advanced Urothelial Carcinoma
Liechtenstein
13 Apr 2022
Locally Advanced Urothelial Carcinoma
Norway
13 Apr 2022
Metastatic urothelial carcinoma
European Union
13 Apr 2022
Metastatic urothelial carcinoma
Iceland
13 Apr 2022
Metastatic urothelial carcinoma
Liechtenstein
13 Apr 2022
Metastatic urothelial carcinoma
Norway
13 Apr 2022
Transitional Cell Carcinoma
United States
18 Dec 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
United States
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
China
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Japan
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Argentina
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Australia
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Belgium
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Canada
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Czechia
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
Denmark
30 Mar 2020
Muscle Invasive Bladder Urothelial CarcinomaPhase 3
France
30 Mar 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
186
caeghsmqiy(ldgwzxsyrd) = Cutaneous toxicities occurred in 106 patients (57%), predominantly within the first 12 weeks (94/106), 70% of events were classified as mild and 30% as moderate/severe pntuemmaok (mqxzjlkkth )
Positive
30 May 2025
Phase 3
886
azkyxewbdr(wsimaofcoq) = xqytkxsipk ntjyrxyjkb (mraeozjfeh )
Positive
30 May 2025
Chemotherapy (gemcitabine + cisplatin/carboplatin)
azkyxewbdr(wsimaofcoq) = zhsqbnqhwt ntjyrxyjkb (mraeozjfeh )
Not Applicable
Metastatic urothelial carcinoma
First line
ECOG ≥2 | age ≥80
116
vhlkmikglm(mlicjhpxdt) = 33.0% xsywtyzrbi (cvgpkocndk )
Positive
30 May 2025
Not Applicable
208
Platinum-based chemotherapy
ldajlzjhfv(miiqeouxds) = efnfxfvtgq ttjqhcuyaq (dtnzrxiaoh, 9.7 - 17)
Positive
30 May 2025
Not Applicable
Metastatic urothelial carcinoma
First line | Third line
HER2 | FGFR
101
bskosvktdy(vuthaqefbm) = ubjdoreclh xrullifimt (vxhylivftq )
Positive
30 May 2025
Platinum-based chemotherapy
rourxwmrno(mzuzjtgppe) = rzjeelbwuw bvfeveeroj (rhmnjtxjst )
Not Applicable
153
qmsuworfnm(lzuqalbarh) = xqvrrkhffr etrecfnnzw (fyorkawiwj )
Positive
30 May 2025
qmsuworfnm(lzuqalbarh) = zbovtxlupt etrecfnnzw (fyorkawiwj )
Phase 1/2
22
amyupuprda(apyxeftoun) = wsvitmglrx yqznyssjbc (douktjkhls, 14.5 - NE)
Positive
30 May 2025
Not Applicable
86
mksdzqhhob(vovumpxnhp) = wowhqbaoeu snzeuqrbpk (gakxrlbcuf )
Positive
30 May 2025
mksdzqhhob(vovumpxnhp) = keargdxbfa snzeuqrbpk (gakxrlbcuf )
Not Applicable
1,311
moxaemeydn(gblfrjcoho) = nyjmoygdkr rvpmjhpfgx (gkbvcdcrvp, 2.35 - 11.74)
Positive
30 May 2025
Enfortumab Vedotin + Pembrolizumab combination therapy
moxaemeydn(gblfrjcoho) = bddvuqyyim rvpmjhpfgx (gkbvcdcrvp, 2.11 - 7.88)
Not Applicable
123
vodmpvgzuz(gsyzizekif) = 14% hyperglycemia ymmttqpwfj (unlkyicsyg )
Positive
30 May 2025
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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