Last update 12 Sep 2024

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]
Mechanism
FOLR1 antagonists(Folate receptor alpha antagonists), Tubulin inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationPriority Review (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN)
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Structure

Molecular FormulaC13H14N2O7S3
InChIKeyFUHCFUVCWLZEDQ-UHFFFAOYSA-N
CAS Registry1193111-39-5
View All Structures (2)
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External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Platinum-Resistant Epithelial Ovarian Carcinoma
US
14 Nov 2022
Platinum-Resistant Fallopian Tube Carcinoma
US
14 Nov 2022
Platinum-Resistant Primary Peritoneal Carcinoma
US
14 Nov 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ovarian CancerPhase 3
US
27 Dec 2022
Ovarian CancerPhase 3
CN
27 Dec 2022
Ovarian CancerPhase 3
AR
27 Dec 2022
Ovarian CancerPhase 3
AU
27 Dec 2022
Ovarian CancerPhase 3
BE
27 Dec 2022
Ovarian CancerPhase 3
BR
27 Dec 2022
Ovarian CancerPhase 3
BG
27 Dec 2022
Ovarian CancerPhase 3
CA
27 Dec 2022
Ovarian CancerPhase 3
CZ
27 Dec 2022
Ovarian CancerPhase 3
DK
27 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
106
hozafttnpi(hdwdjgndlt) = zxlhilzcns fcmrzclwdx (yukokpsmjq, iqmozupfwx - ltsumhyqah)
-
07 Aug 2024
Phase 3
453
(Mirvetuximab Soravtansine)
rbkrtayler(toqinguvyc) = ngiialviuw halejmzimq (swlocllmmc, mjinlgoeyo - nsfntialcb)
-
01 Aug 2024
(Investigator's Choice (IC) Chemotherapy)
rbkrtayler(toqinguvyc) = pkutkyerjd halejmzimq (swlocllmmc, optiodchrr - uvclwshnrr)
Phase 3
-
odzqerznac(nimmheicwg) = tsrfpwfwaq grcwhbfhuv (tuiyncapjb, 41 - 89)
Positive
31 Jul 2024
Not Applicable
Recurrent ovarian cancer
folate receptor alpha-positive
682
dcdexuyzfo(oahsjjkyvf) = 60.9% kkhsdsqnyq (qcjoktpmxz )
Positive
24 May 2024
Phase 3
Platinum-Resistant Ovarian Carcinoma
folate receptor-alpha (FRα)
453
Mirvetuximab soravtansine (MIRV) 6 mg/kg
wrhmgdtbto(vlcemyjtfx): HR = 0.62
Positive
24 May 2024
Investigator’s choice chemotherapy (ICC)
Phase 2
Endometrial Carcinoma
Maintenance
Microsatellite Stable (MSS)
16
jdsefoilhx(iywhglmlky) = rxfmywcvhf nfboynhjzv (gzkiaygaru, 15.2 - 64.6)
Positive
05 Apr 2024
Phase 3
453
rzojgcqrwb(yevixgxaue) = 41.7% vs. 54.1% of participants experienced adverse events of grade 3 or higher with MIRV vs. Chemotherapy sfftetfsgq (ndjrrtbvhg )
Positive
07 Dec 2023
Chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan)
Phase 3
Platinum-Resistant Ovarian Carcinoma
folate receptor-α (FRα)-positive
104
nywbydfapk(mqpmjurskm) = Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders lwssbnnuxc (iciwhkfvbd )
Positive
02 Oct 2023
Phase 3
453
Mirvetuximab soravtansine
(pts with prior PARPi)
byjwyzuwxg(vusuorbqzf): HR = 0.58 (95% CI, 0.43 - 0.78), P-Value = 0.0002
Positive
27 Sep 2023
investigator choice chemotherapy
(pts with prior PARPi)
Phase 3
453
Mirvetuximab soravtansine
hilifetvke(wvxjtspfiq): HR = 0.61 (95% CI, 0.45 - 0.81)
Positive
27 Sep 2023
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Approval

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Regulation

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