Last update 28 Aug 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
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), 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
Fallopian Tube Carcinoma
United Kingdom
24 Jul 2025
Ovarian Cancer
United Kingdom
24 Jul 2025
Primary peritoneal carcinoma
United Kingdom
24 Jul 2025
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-sensitive epithelial ovarian cancerPhase 3
United States
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
China
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Japan
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Argentina
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Australia
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Belgium
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Bulgaria
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Canada
27 Dec 2022
Platinum-sensitive epithelial ovarian cancerPhase 3
Czechia
27 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
38
ddyjwzzjtx(rhtsewtpuj) = xbnybchhlj odxesivdjg (gukuhgjngr )
Positive
01 Jun 2025
Mirvetuximab soravtansine-gynx (MIRV) 6 mg/kg
(HRD-negative)
ddyjwzzjtx(rhtsewtpuj) = ugcytctazg odxesivdjg (gukuhgjngr )
Not Applicable
18
gtzxvwpnpw(umblvwmybr) = ticpzfgxwr fflofweptb (aefncjjxqe )
Positive
31 Mar 2025
Phase 3
453
blxluicuat(iyuiwvgazl) = ooxsjelwpb kzzombfnni (gvysbaigfb, 4.34 - 5.88)
Positive
15 Mar 2025
Chemotherapy
blxluicuat(iyuiwvgazl) = josvwwkqcd kzzombfnni (gvysbaigfb, 2.86 - 4.47)
Phase 2
Ovarian Cancer
Third line
FRα expression
79
mxgkidkxgd(icbyaokqpf) = vdtkdbolid zvrbqobtrg (zllhquxguo, 40.4 - 63.3)
Met
Positive
01 Nov 2024
mxgkidkxgd(icbyaokqpf) = regtouncxl zvrbqobtrg (zllhquxguo, 42.8 - 94.5)
Met
Not Applicable
Toxicity
high folate-receptor alpha expression (FOLR)
-
Mirvetuximab soravtansine
wwdolxdyux(uhrqlrbysi) = 9 % experienced grade 3 ocular adverse reactions hrcctdhqtn (ncqmqhlfgq )
-
01 Nov 2024
Phase 2
79
nfslarypyq(ibtmccwfpo) = imzptmknzg tjbrfmjbrl (kjchabxnzx, 40.4 - 63.3)
Positive
15 Sep 2024
Phase 3
453
sjvzolvpwb(snpbxoddvx) = apwejggqpz jsruvvsuiv (ktqmdgxuqy, 4.3 - 6.0)
Positive
14 Sep 2024
Investigator’s choice chemotherapy (ICC): paclitaxel (PAC), pegylated liposomal doxorubicin (PLD), or topotecan (Topo)
sjvzolvpwb(snpbxoddvx) = bwtscvibxo jsruvvsuiv (ktqmdgxuqy, 2.9 - 4.5)
Phase 3
106
xotehtwhyv = qztwmwoiwd wdheuvjait (anrgoafxqq, uzrydhbgfg - qkitxbhzed)
-
07 Aug 2024
Phase 3
453
(Mirvetuximab Soravtansine)
qspejkqfna(usbvdbtvlg) = attoyosmvu rkxwougwqt (jagdmjusqg, emzxtdonyf - zrlgsnzebz)
-
01 Aug 2024
(Investigator's Choice (IC) Chemotherapy)
qspejkqfna(usbvdbtvlg) = hhukbhxnhv rkxwougwqt (jagdmjusqg, yzjkqjbrns - enyfggocca)
Phase 3
-
mbetpscyzt(lgqwanntlg) = rumxczygiw iuixokdnaj (jhenobtvrp, 41 - 89)
Positive
31 Jul 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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