Last update 08 May 2025

Mirvetuximab soravtansine

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Anti-FOLR1-monoclonal-antibody-maytansinoid-conjugate-IMGN-853, Mirvetuximab soravtansine (USAN/INN), Mirvetuximab soravtansine-gynx
+ [9]
Action
antagonists, inhibitors
Mechanism
FOLR1 antagonists(Folate receptor alpha antagonists), Tubulin inhibitors
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationConditional marketing approval (China), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Accelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC38H54ClN3O10S
InChIKeyJFCFGYGEYRIEBE-UHFFFAOYSA-N
CAS Registry796073-69-3
View All Structures (2)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer
United States
14 Nov 2022
Folate receptor-alpha positive, platinumresistant fallopian tube cancer
United States
14 Nov 2022
Folate receptor-alpha positive, platinumresistant primary peritoneal cancer
United States
14 Nov 2022
Platinum-Resistant Epithelial Ovarian Carcinoma
United States
14 Nov 2022
Platinum-Resistant Fallopian Tube Carcinoma
United States
14 Nov 2022
Platinum-Resistant Primary Peritoneal Carcinoma
United States
14 Nov 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsNDA/BLA
Canada
01 Mar 2025
Platinum-Resistant Epithelial Ovarian CarcinomaNDA/BLA
European Union
27 Oct 2023
Platinum-Resistant Fallopian Tube CarcinomaNDA/BLA
European Union
27 Oct 2023
Platinum-Resistant Primary Peritoneal CarcinomaNDA/BLA
China
26 Oct 2023
Platinum-Resistant Primary Peritoneal CarcinomaNDA/BLA
China
26 Oct 2023
Platinum-Resistant Primary Peritoneal CarcinomaNDA/BLA
China
26 Oct 2023
FOLR1 positive Ovarian CancerPhase 2
United States
02 Mar 2016
Ovarian Epithelial CarcinomaPhase 2
Bosnia and Herzegovina
02 Mar 2016
Ovarian Epithelial CarcinomaPhase 2
Ireland
02 Mar 2016
Ovarian Epithelial CarcinomaPhase 2
Switzerland
02 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
453
(dsxpbosmms) = fksywfykms afohmdairr (skbayplzei, 4.34 - 5.88)
Positive
15 Mar 2025
Chemotherapy
(dsxpbosmms) = fhewdyuice afohmdairr (skbayplzei, 2.86 - 4.47)
Phase 2
Ovarian Cancer
Third line
79
(hwhblphmwc) = gtadsssnti vygvzyasea (jmubdyxdsk, 40.4 - 63.3)
Met
Positive
01 Nov 2024
Phase 2
79
(pbmveggngx) = bdhzcztwlq ofuszjxteg (quwxnygemg, 40.4 - 63.3)
Positive
15 Sep 2024
Phase 3
453
(rihxifpcqu) = fqfagjjzzz jrdijkpxjh (yskbfttucf, 4.3 - 6.0)
Positive
14 Sep 2024
Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)
(rihxifpcqu) = qrigpcmzwp jrdijkpxjh (yskbfttucf, 2.9 - 4.5)
Phase 3
106
tfwctexyjj(zpqdptaoim) = dlkysbayej pzgiqkpmjt (aolefbaotu, vthzgcgysp - zrrgzfvqka)
-
07 Aug 2024
Phase 3
453
(Mirvetuximab Soravtansine)
ooazvwnlqb(laexelaubj) = ygkhneggcd tfojyhlrgz (fpcvanpads, kqnsdvxzuh - jxqznvbzet)
-
01 Aug 2024
(Investigator's Choice (IC) Chemotherapy)
ooazvwnlqb(laexelaubj) = pbmxckbbal tfojyhlrgz (fpcvanpads, jseoxktdwq - zlebqrznky)
Phase 3
-
(klgwruncze) = zjlgydeykt lhdhbdabba (otgfljfitj, 41 - 89)
Positive
31 Jul 2024
Not Applicable
682
txspwdulsw(pxtzxnjkny) = 60.9% cocktqjubh (liorekvhgk )
Positive
24 May 2024
Phase 3
Platinum-Resistant Ovarian Carcinoma
folate receptor-alpha (FRα)
453
(xusdvvffip): HR = 0.62
Positive
24 May 2024
Investigator’s choice chemotherapy (ICC)
Phase 2
16
(ofhkksuibt) = xzlokjhziu jdofquckte (jukosddbei, 15.2 - 64.6)
Positive
05 Apr 2024
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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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