mirvetuximab soravtansine

Trade name: Elahere

mAbapprovedADCOrphan Drug FDAFast Track FDA

Approved

Nov 14, 2022

ImmunoGen, Inc. was a biotechnology company focused on the development of antibody-drug conjugate (ADC) therapeutics for the treatment of cancer. ImmunoGen was founded in 1981 and was headquartered in Waltham, Massachusetts. — Wikipedia

Clinical trial activity

25 trials · 24 clinical orgs · 1 marketing orgs

Phase 1
7
Phase 2
19
Phase 3
6
Phase 4
0

Earliest trial started May 1, 2012 (NCT01609556)

Timeline

2010s

  1. Jan 1, 2012

    Immunogen — Earliest Phase 1 Sponsor(trial)

  2. Jul 14, 2014

    Orphan Drug Designation

  3. Jan 1, 2016

    Immunogen — Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Nov 14, 2022

    Immunogen — Earliest FDA Approval

  2. Nov 14, 2022

    Immunogen — Marketing Organization

  3. Nov 14, 2022

    Immunogen — NDA Secondary Org

  4. Nov 14, 2022

    Immunogen — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackNov 14, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No
Payload
Ravtansine

Oral

No

Parenteral

Yes

Topical

No

Black box warningFirst in class

Sources

Also known as

  • imgn853
  • imgn853
  • imgn853
  • imgn-853
  • mirvetuximab soravtansine
  • mirvetuximab soravtansine
  • mirvetuximab soravtansine
  • mirvetuximab soravtansine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07218809Phase 3Nov 28, 2025AstraZeneca, European Network for Gynaecological Oncological Trial, GOG Foundation, Inc.
NCT06890338Phase 2Nov 21, 2025AbbVie, GOG Foundation, Inc.
NCT07059845Phase 2Nov 13, 2025AbbVie
NCT06682988Phase 3Feb 6, 2025AbbVie
NCT06365853Phase 2Jul 29, 2024AbbVie
NCT06390995Phase 1/Phase 2 (Phase 2)May 20, 2024Takeda
NCT05887609Phase 2Oct 3, 2023Immunogen, University of Colorado, Denver
NCT05456685Phase 2Sep 28, 2022AbbVie, Immunogen
NCT05622890Phase 3Aug 18, 2022Hangzhou Zhongmei
NCT05483933Phase 1Aug 18, 2022Shattuck Labs
NCT05041257Phase 2Aug 31, 2021Immunogen, IQVIA
NCT04606914Phase 2May 27, 2021University of Alabama, Birmingham
NCT04274426Phase 2Jul 31, 2020AGO Germany
NCT04296890Phase 3Apr 30, 2020Immunogen, IQVIA
NCT04209855Phase 3Dec 31, 2019Gynecologic Oncology Group, Immunogen
NCT03832361Phase 2Aug 31, 2019Immunogen, Yale University
NCT03836157Phase 2May 31, 2019Immunogen, University of Oklahoma
NCT03835819Phase 2Mar 31, 2019Harvard University, Immunogen, Merck
NCT03552471Phase 1Jul 12, 2018Clovis Oncology, Immunogen, Ohio State University
NCT03106077Phase 2Jun 5, 2017National Comprehensive Cancer Network, University of Texas at Houston
Showing 20 of 25 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ImmunogenFor profit12732012
AbbVieFor profit5522022
GOG Foundation, Inc.Academic/Hospital2022025
Gynecologic Oncology GroupAcademic/Hospital2012016
IQVIAFor profit2022020
National Comprehensive Cancer NetworkAcademic/Hospital2022017
AGO GermanyAcademic/Hospital1112020
AstraZenecaFor profit1112025
City of Hope National Medical CenterAcademic/Hospital1112017
Clovis OncologyFor profit1012018
Duke UniversityAcademic/Hospital1112017
European Network for Gynaecological Oncological TrialAcademic/Hospital1012025
Hangzhou ZhongmeiFor profit1112022
Harvard UniversityAcademic/Hospital1112019
MerckFor profit1012019
National Cancer Institute (NCI)Government1012017
Ohio State UniversityAcademic/Hospital1112018
Shattuck LabsFor profit1112022
TakedaFor profit1112024
University of Alabama, BirminghamAcademic/Hospital1112021
24 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
ImmunogenFor profitMKTGNov 14, 2022
ImmunogenFor profitNDA2Nov 14, 2022
ImmunogenFor profitNDANov 14, 2022