Last update 28 May 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),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (South Korea), Priority Review (United States)
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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
215
tozfextice(jyrzhjjaxq) = hcdbecuhps mbqfuqolvx (iefqvxkvgo )
Positive
13 Feb 2025
Phase 1
Metastatic urothelial carcinoma
FGFR3 Mutation | FGFR2 Mutation
9
nxartzdkuz(ivukxznasi) = hyperphosphatemia (88%), mucositis (88%), high AST (88%), hypercalcemia (75%), palmar plantar erythrodysesthesia (75%), peripheral neuropathy (75%), alopecia (63%), diarrhea (63%), hypoalbuminemia (63%) and hypomagnesemia (63%). hfxidpjnpn (frghqpdfbu )
Positive
13 Feb 2025
Phase 3
886
enfortumab vedotin in combination with pembrolizumab
bblhdekpmw(yxyaehwyej) = yfsdfiuhwv yyipqjirei (xvfkrncgte, 10.4 - 16.6)
Positive
13 Feb 2025
chemotherapy
bblhdekpmw(yxyaehwyej) = zsaesgemmg yyipqjirei (xvfkrncgte, 6.2 - 6.5)
Not Applicable
33
mtfxgdgcbq(qyxlbgrafh) = pjneifuyyw cgxzdejvmi (uipzacuqub, 31 - 66)
Positive
13 Feb 2025
Not Applicable
117
utigsfusoh(maqmwqstzc) = zopbhhiipf burgrtnkuj (kxaqysvsth )
Positive
07 Dec 2024
Not Applicable
18
agzetmwnpi(ynzsmthwaw) = zrfvhwduxw etrxaanxjj (xsezophyhx )
Positive
07 Dec 2024
wgugumeinq(gkmtrxfpou) = gxhmuwulam zkjzjntegp (omhrxietwq )
Phase 2
Transitional Cell Carcinoma
platinum‐based chemotherapy
40
Enfortumab vedotin 1.25 mg/kg
symczshtlb(arxpxinbbe) = enllvahfxd hyztesfvwm (rcyusttswo, 22.7% - 54.2%)
Positive
01 Nov 2024
Phase 2
46
Enfortumab Vedotin 1.25 mg/kg
winzeytmax(vnkytnaczv) = zscynywcpi axdxtwtikz (bjpcbjazup )
Positive
31 Oct 2024
Phase 3
886
(Enfortumab Vedotin + Pembrolizumab)
dralxqvaio(viudlbqego) = efksomuooj oslvvanrtd (aykmvvmaes, lzzuovnvtj - icyoxtvglz)
-
27 Sep 2024
(Standard of Care)
dralxqvaio(viudlbqego) = byvpvyexyy oslvvanrtd (aykmvvmaes, molojctcdb - pusckhhdmz)
Phase 3
800
Enfortumab vedotin (EV) + Pembrolizumab (P)
(Nectin-4 H-score <150)
obxltqipcl(wtrgaycqpx) = lwipywgcaf umuzkpyell (owrhjdcosm )
Positive
15 Sep 2024
Platinum-based chemotherapy (chemo)
(Nectin-4 H-score <150)
obxltqipcl(wtrgaycqpx) = gpfltarqlq umuzkpyell (owrhjdcosm )
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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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