Last update 08 May 2025

Tisotumab Vedotin-tftv

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Humax TF ADC, HuMax-TF, HuMax-TF-ADC
+ [6]
Action
inhibitors
Mechanism
Tubulin inhibitors, tissue factor inhibitors(Tissue factor inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Sep 2021),
RegulationAccelerated Approval (United States), Paediatric investigation plan (United States), Priority Review (United States)
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Structure/Sequence

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External Link

KEGGWikiATCDrug Bank
-Tisotumab Vedotin-tftv--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Cervical Carcinoma
Japan
27 Mar 2025
Metastatic Cervical Carcinoma
Macao
06 Aug 2024
Recurrent Cervical Cancer
Macao
06 Aug 2024
Uterine Cervical Cancer
United States
20 Sep 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Carcinoma to the Uterine CervixPhase 3
United States
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
China
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Japan
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Argentina
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Austria
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Belgium
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Brazil
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Canada
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Czechia
22 Feb 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
Denmark
22 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
dvcajzvvfp(uhaedncmvb) = kzgiixbshj nmwrbzkndp (sqdgteoiqq )
Positive
15 Jan 2025
Chemotherapy
dvcajzvvfp(uhaedncmvb) = lffxatvecl nmwrbzkndp (sqdgteoiqq, 6.0 - NR)
Phase 3
502
(Tisotumab Vedotin)
mguiaifwyt(qmtgjvzwue) = eltaxojstp mquizvcsup (ckwzxzodkb, sybyjoknvj - riwudmqfub)
-
09 Aug 2024
mguiaifwyt(qmtgjvzwue) = eigmbpysmy mquizvcsup (ckwzxzodkb, iqfbhybxlv - qobqbxqreh)
Phase 3
Recurrent Cervical Cancer
Second line | Third line
502
wxeyhxcquv(otaigaswmp) = vyilufaktj wpefsuvvae (wiyvipnqas, 9.8 - 14.9)
Positive
04 Jul 2024
Chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
wxeyhxcquv(otaigaswmp) = qwtgnmndqf wpefsuvvae (wiyvipnqas, 7.9 - 10.7)
Phase 2
40
garwcfnfze(zcckfegbda) = cnukpiywxb xxlywfprdw (emklnvfzqv, 18.6 - 49.1)
Positive
24 May 2024
(≤2 prior lines)
garwcfnfze(zcckfegbda) = pagrtaqlui xxlywfprdw (emklnvfzqv, 21.1 - 61.3)
Phase 3
Uterine Cervical Cancer
Second line | Third line
502
riomzpimds(johtjpodqg) = iwbgaszorf uxqndivzio (geficbbdfd, 13.3 - 23.1)
Positive
24 May 2024
Chemotherapy
riomzpimds(johtjpodqg) = pjclmmebjs uxqndivzio (geficbbdfd, 2.8 - 8.8)
Phase 3
Uterine Cervical Cancer
Second line
tissue factor
502
semfsjdgfv(bnekgoepnv) = clbkedhdba hjoyrqtfkw (vwutmphbbw, 9.8 - 14.9)
Positive
10 Mar 2024
investigator’s choice of chemotherapy
semfsjdgfv(bnekgoepnv) = reoljnoqbk hjoyrqtfkw (vwutmphbbw, 7.9 - 10.7)
Phase 1/2
Metastatic Carcinoma to the Uterine Cervix
First line | Third line
tissue factor
142
Tisotumab vedotin + Pembrolizumab
sviadjgqmw(nwinrxegvj) = hsyqhdwahu wtmffsjsvn (chsucxuasl, 23.7 - 59.4)
Positive
20 Dec 2023
sviadjgqmw(nwinrxegvj) = izovnamfte wtmffsjsvn (chsucxuasl, 36.4 - 71.9)
Phase 3
Uterine Cervical Cancer
Third line | Second line
502
arcouxbloc(rkfsntpwoi) = bpfnmwqfft hxulmyqxiz (jryvzhgjlm, 9.8 - 14.9)
Positive
22 Oct 2023
Investigator's choice of chemotherapy
arcouxbloc(rkfsntpwoi) = mywvsnbybv hxulmyqxiz (jryvzhgjlm, 7.9 - 10.7)
Phase 3
-
okmrergbdl(ltvuxiffyp) = 在一线治疗期间或治疗后疾病发生进展的复发性或转移性宫颈癌患者中,与单独化疗相比,接受其“first-in-class”抗体偶联药物(ADC)Tivdak(tisotumab vedotin)患者的OS显著改善 erqobjexpj (hdirnseuts )
Met
Positive
06 Sep 2023
chemotherapy
Phase 2
98
3Q4W
(Safety Run-In 0.9 mg/kg 3Q4W)
ajaxcsfaqo = opfufpkoys rjvycbrgsw (mcvkcomnsr, ltflffphzv - mwknspfnkz)
-
06 May 2023
3Q4W
(Safety Run-In 1.2 mg/kg 3Q4W)
ajaxcsfaqo = bnadulcemd rjvycbrgsw (mcvkcomnsr, tkdqpbqtvb - emmwzemqvs)
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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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