Mirvetuximab soravtansine
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Mirvetuximab soravtansine
- elahere
- Elahere
- elahere
- Elahere
- imgn 853
- IMGN-853
- imgn853
- IMGN853
- immunoglobulin g1 anti human folate receptor α human mus musculus monoclonal m9346a heavy chain disulfide with human mus musculus monoclonal m9346a light chain dimer tetraamide with n2 4 3 carboxy 3 sulfopropyl dithio 4 methyl 1 oxopentyl n2 deacetylmaytansine
- immunoglobulin g1 kappa anti human folate receptor alpha adult folatebending protein folate receptor 1 kb cells fbp ovarian tumor associated antigen mov18 humanized mouse monoclonal antibody linked to an average of four molecules of maytansine acid derivative amide between an average of four molecules of 2rs 12s 14 1s 2r 3s 5s 6s 16e 18e 20r 21s 11 chloro 21 hydroxy 12 20 dimethoxy 2 5 9 16 tetramethyl 8 23 dioxo 4 24 dioxa 9 22 diazatetracyclo 19 3 1 110 14 03 5 hexacosa 10 12 14 26 16 18 pentaen 6 yl 7 7 11 12 tetramethyl 10 13 dioxo 2 sulfonyl 14 oxa 5 6 dithia11 azatetradecanoic acid and an average of four amino groups of γ1 heavy chain 1 447 mus musculus vh ighv1 37 01 ighd ighj4 01 88 8 8 11 1 119 des ch3k107 448 ighg1 01 119 447 221 218 disulfide with kappa light chain 1 218 mus musculus v kappa igkv3 9 01 igkj1 02 81 10 3 9 1 111 igkc 01 112 218 dimer 227 227 230 230 bisdisulfide
- Immunoglobulin G1-kappa, anti-(human folate receptor alpha (adult folatebending protein, folate receptor 1, KB cells FBP, ovarian tumor-associated antigen Mov18)); humanized mouse monoclonal antibody linked to an average of four molecules of maytansine acid derivative : amide between an average of four molecules of (2RS,12S)-14-[(1S,2R,3S,5S,6S,16E,18E,20R,21S)-11- chloro-21-hydroxy-12,20-dimethoxy-2,5,9,16-tetramethyl-8,23-dioxo-4,24- dioxa-9,22-diazatetracyclo[19.3.1.110.14.03.5]hexacosa-10,12,14(26),16,18- pentaen-6-yl]-7,7,11,12-tetramethyl-10,13-dioxo-2-sulfonyl-14-oxa-5,6-dithia11-azatetradecanoic acid and an average of four amino groups of γ1 heavy chain (1-447) [Mus musculus VH (IGHV1-37*01–(IGHD)-IGHJ4*01) (88%) [8.8.11] (1-119) –des-(CH3K107 (448))-IGHG1*01 (119-447)] (221-218')- disulfide with kappa light chain (1'-218') [Mus musculus V-KAPPA (IGKV3-9*01-IGKJ1*02) (81%) [10.3.9] (1'-111') -IGKC*01 (112'-218')] dimer (227-227'':230-230'')-bisdisulfide
- Immunoglobulin G1, anti-(human folate receptor α) (human-Mus musculus monoclonal M9346A heavy chain), disulfide with human-Mus musculus monoclonal M9346A light chain, dimer, tetraamide with N2'-[4-[(3-carboxy-3- sulfopropyl)dithio]-4-methyl-1-oxopentyl]-N2'-deacetylmaytansine
- mirvetuximab soravtansina
- Mirvetuximab soravtansina
- mirvetuximab soravtansine
- Mirvetuximab soravtansine
- Mirvetuximab Soravtansine
- Mirvetuximab Soravtansine (IMGN853)
- Mirvetuximab Soravtansine (MIRV)
- mirvetuximab soravtansine [INN]
- Mirvetuximab soravtansine [MI]
- MIRVETUXIMAB SORAVTANSINE [USAN]
- Mirvetuximab soravtansine [WHO-DD]
- mirvetuximab soravtansine gynx
- Mirvetuximab soravtansine gynx
- Mirvetuximab soravtansine gynx [WHO-DD]
- mirvetuximab soravtansine gynx who dd
And 6 more, listed on the interactive page.
- ATC classification codes
- L01FX26
Sources for recorded values
- CAS registry numbers
- 1453084-37-1
- ChEMBL ID
- CHEMBL3545132
- PubChem compound IDs
- 91810695
- FDA ingredient codes (UNII)
- 98DE7VN88D
- 2621548
- 2621549
- Applicant
- IMMUNOGEN INC
- Approval date
- 14 Nov 2022
- Application number
- BLA761310
- Status
- Authorised
- Status date
- 14 Nov 2024
- Authorisation date
- 14 Nov 2024
- Approved indications
- Elahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
- Product number
- EMEA/H/C/005036
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Fallopian Tube Neoplasms
- Ovarian Neoplasms
- Peritoneal Neoplasms
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 14 Nov 2029
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- mirvetuximab soravtansine
- Type
- Antibody
- Drug name stem
- -mab; -tansine
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Folate receptor alpha binding agent
- Action type
- BINDING_AGENT
- Target
- Folate receptor alpha
- Protein identifier
- P15328
- Action
- Binding
- Action type
- Binding
- Target
- folate receptor alpha
- Gene symbol
- FOLR1
- Protein identifier
- P15328
- Median affinity
- 10.1
- Affinity units
- pKd
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Mechanism
- Folate receptor alpha binding agent
- Action type
- BINDING AGENT
- Target
- Folate receptor alpha
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Peritoneal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001100
- Subject identifier
- D010534
- Condition
- Breast Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Endometrial Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0011962
- Subject identifier
- D016889
- Condition
- Carcinoma, Ovarian Epithelial
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018364
- Subject identifier
- D000077216
- Condition
- Fallopian Tube Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0021092
- Subject identifier
- D005185
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003893
- Condition identifier
- EFO_0005537
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001100
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005140
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005494
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006206
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006901
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007254
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007254
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008170
- Condition identifier
- MONDO_0008170
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0011962
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0015686
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018364
- Condition identifier
- MONDO_0018364
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0021068
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0021092
- Condition identifier
- MONDO_0021092
- Highest recorded phase
- 4
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
Reported adverse events
- Event
- treatment failure
- Reports
- 3
- Reporting signal score
- 10.1159
- NCT01609556
- NCT03045393
- NCT03106077
- NCT03832361
- NCT03835819
- NCT03836157
- Dose
- 6 mg/kg
- Route
- Intravenous
- How often
- Every 3 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVVKPGASVKISCKASGYTFTGYFMNWVKQSPGQSLEWIGRIHPYDGDTFYNQKFQGKATLTVDKSSNTAHMELLSLTSEDFAVYYCTRYDGSRAMDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVLTQSPLSLAVSLGQPAIISCKASQSVSFAGTSLMHWYHQKPGQQPRLLIYRASNLEAGVPDRFSGSGSKTDFTLTISPVEAEDAATYYCQQSREYPYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 72903-853
Related records
Trials (28)
- A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC)
- A Real-world Study of Mirvetuximab Soravtansine (MIRV) in Ovarian Cancer Patients of Expression of Folate Receptor α（FRα）
- A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer
- A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
- A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
- A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
- A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
- A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
- A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer
- A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
- A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
- An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
- AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
- Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
- First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
- Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC
- Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
- Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer
- Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer
Approved for (4)
- Fallopian tube neoplasm
- Malignant epithelial tumor of ovary
- Neoplasm
- Peritoneal neoplasm
In development for (3)
- Breast cancer Phase 1
- Endometrial cancer Phase 2
- Triple-negative breast carcinoma Phase 2
Other linked conditions (2)
Targets (16)
- FOLR1 Folate receptor alpha binding agent
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor