Linvoseltamab
Highest phase reached
Phase 3
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody
- Drug name
- Linvoseltamab
- human igg4 based anti cd3 x anti bcma bispecific monoclonal antibody that binds to cd3 and bcma
- Human IgG4-based anti-CD3 x anti-BCMA bispecific monoclonal antibody that binds to CD3 and BCMA
- IMMUNOGLOBULIN G4 (103-CYSTEINE,108-CYSTEINE,233-PROLINE,238-PROLINE,239-VALINE,240-ALANINE,DE-241-GLYCINE), ANTI-(HUMAN B-CELL MATURATION ANTIGEN) (HUMAN MONOCLONAL REGN5458 .GAMMA.4-CHAIN), DISULFIDE WITH HUMAN MONOCLONAL REGN5458 .KAPPA.-CHAIN, (231->230'),(234->233')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G4 (232-PROLINE,237-PROLINE,238-VALINE,239-ALANINE,DE-240-GLYCINE,439-ARGININE,440-PHENYLALANINE,449-PROLINE) ANTI-(HUMAN CD3 ANTIGEN) (HUMAN MONOCLONAL REGN5458 .GAMMA.4-CHAIN) DISULFIDE WITH HUMAN MONOCLONAL REGN5458 .KAPPA.-CHAIN
- immunoglobulin g4 103 cysteine 108 cysteine 233 proline 238 proline 239 valine 240 alanine de 241 glycine anti human b cell maturation antigen human monoclonal regn5458 gamma 4 chain disulfide with human monoclonal regn5458 kappa chain 231 230 234 233 bis disulfide with immunoglobulin g4 232 proline 237 proline 238 valine 239 alanine de 240 glycine 439 arginine 440 phenylalanine 449 proline anti human cd3 antigen human monoclonal regn5458 gamma 4 chain disulfide with human monoclonal regn5458 kappa chain
- linvoseltamab
- Linvoseltamab
- linvoseltamab [INN]
- LINVOSELTAMAB [USAN]
- Linvoseltamab [WHO-DD]
- linvoseltamab gcpt
- linvoseltamab inn
- linvoseltamab usan
- linvoseltamab who dd
- Linvoseltamab-GCPT
- lynozyfic
- LYNOZYFIC
- regn 5458
- REGN-5458
- regn5458
- REGN5458
- CAS registry numbers
- 2408319-25-3
- ChEMBL ID
- CHEMBL5095373
- RxNorm IDs (RxCUI)
- 2719416
- FDA ingredient codes (UNII)
- M3CPC50MZS
- L01FX
- L01FX37
Sources for recorded values
- Status
- Authorised
- Status date
- 23 Apr 2025
- Authorisation date
- 23 Apr 2025
- Approved indications
- Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
- Product number
- EMEA/H/C/006370
- Authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- Yes
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Myeloma
European medicines record
- Patents
- 0
- Designations
- 4
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Pharmacology name
- linvoseltamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- CD3e
- Gene symbol
- CD3E
- Protein identifier
- P07766
- Median affinity
- 6.92
- Affinity units
- pEC50
- Action
- Binding
- Action type
- Binding
- Target
- B cell maturation antigen
- Gene symbol
- TNFRSF17
- Protein identifier
- Q02223
- Median affinity
- 7.64
- Affinity units
- pEC50
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Food Hypersensitivity
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001890
- Subject identifier
- D005512
- Condition
- Amyloidosis, Familial
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0019438
- Subject identifier
- D028226
- Condition identifier
- EFO_0000200
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_1000836
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001890
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004959
- Condition identifier
- MONDO_0005070
- Condition identifier
- MONDO_0005235
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0009693
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0019438
- Condition identifier
- MONDO_0700226
- Highest recorded phase
- 1
- NCT03761108
- NCT05137054
- NCT05730036
- NCT05828511
- NCT05955508
- NCT06376526
- NCT05092347
- NCT06292780
- NCT06369467
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain: anti-TNFRSF17 (H)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSNFWMTWVRQAPGKGLEWVANMNQDGSEKYYVDSVKGRFTISRDNAKSSLYLQMNSLRAEDTAVYYCARDREYCISTSCYDDFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain: (X', X''')
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSYSTPPITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Sequence: REGN5458 Heavy Chain X'' (anti-CD3)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYSMHWVRQAPGKGLEWVSGISWNSGSKGYADSVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCAKYGSGYGKFYHYGLDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNRFTQKSLSLSPGK
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 135'-195' $ 135'''-195''' $ 139-215' $ 138''-215''' $ 103-108 $ 151''-207'' $ 152-208 $ 231-230'' $ 234-233'' $ 264''-324'' $ 265-325 $ 370''-428'' $ 371-429
Related records
Trials (21)
- A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
- A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
- A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
- A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
- A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
- A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
- A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
- A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
- A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
- A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
- A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
- A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
- Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
- BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)
- Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
- Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
- IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
- Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
- Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
- Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma
In development for (6)
- AL amyloidosis Phase 1
- Chronic kidney disease Phase 1
- Food allergy Phase 1
- Neoplasm Phase 2
- Plasma cell myeloma Phase 3
- Plasma cell neoplasm Phase 1