Last update 08 Jul 2025

Linvoseltamab-gcpt

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
BCMAxCD3 antibody, BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.), Linvoseltamab
+ [4]
Action
inhibitors, stimulants
Mechanism
BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (European Union)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Multiple Myeloma
European Union
23 Apr 2025
Refractory Multiple Myeloma
Iceland
23 Apr 2025
Refractory Multiple Myeloma
Liechtenstein
23 Apr 2025
Refractory Multiple Myeloma
Norway
23 Apr 2025
Relapse multiple myeloma
European Union
23 Apr 2025
Relapse multiple myeloma
Iceland
23 Apr 2025
Relapse multiple myeloma
Liechtenstein
23 Apr 2025
Relapse multiple myeloma
Norway
23 Apr 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaPhase 3-01 Sep 2025
Residual NeoplasmPhase 2
United States
01 Aug 2025
Monoclonal Gammopathy of Undetermined SignificancePhase 2
United States
16 Sep 2024
Monoclonal Gammopathy of Undetermined SignificancePhase 2
Spain
16 Sep 2024
Immunoglobulin Light-Chain AmyloidosisPhase 2
United States
07 Aug 2024
Immunoglobulin Light-Chain AmyloidosisPhase 2
South Korea
07 Aug 2024
Immunoglobulin Light-Chain AmyloidosisPhase 2
Spain
07 Aug 2024
Immunoglobulin Light-Chain AmyloidosisPhase 2
United Kingdom
07 Aug 2024
Smoldering Multiple MyelomaPhase 2
Spain
30 Jan 2024
Food HypersensitivityPhase 1
United States
17 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
117
wdulpiklak(ybaymuguuf) = fxcaiocyqz wlvouzczbc (dnoimocqmy )
Positive
03 Jul 2025
Phase 1
22
Linvoseltamab (LINVO)
srjkgwpfny(fkbogtzfyn) = rlxhabhpqv otaywweqwl (mrpmagnmyr, 47 - 99)
Positive
30 May 2025
Phase 1
18
uqgtwuzble(xslgnzetwq) = bilwvfxnqq cwayhsgmff (udjglfhcmf )
Positive
30 May 2025
uqgtwuzble(xslgnzetwq) = wkyogsphmu cwayhsgmff (udjglfhcmf )
Phase 1
18
boxihvxqgn(poplxfkavx) = izmbawukqr xijcvsiqll (hsdjcbzaqb )
Positive
22 May 2025
boxihvxqgn(poplxfkavx) = nskltcrowr xijcvsiqll (hsdjcbzaqb )
Phase 1
Relapse multiple myeloma
TCE | PI-refractory
22
eqyzowxmfw(ajxqdpxgne) = mawjqdjdyx rkqslnxddo (ejmpmktjfy, 47 - 99)
Positive
22 May 2025
Phase 1/2
Multiple Myeloma
high-risk cytogenetics | penta-refractory disease
117
Linvoseltamab 50 mg
vjkrzoweao(udslralzwe) = ckwnrbzaux uvqjxmvelk (dmrrnvhfci )
Positive
16 Jun 2024
vjkrzoweao(udslralzwe) = qvdcownyyp uvqjxmvelk (dmrrnvhfci )
Phase 1/2
221
xhpfztboem(tpnwzhvadr) = ipsxxgypre jezqaypvru (rpzwjeclrp )
Positive
14 May 2024
Phase 1/2
117
wroyrwptyp(tlzykkjvyh) = bewvlafite uasryutazk (elbibmmijr )
Positive
05 Apr 2024
Phase 2
117
xydnaeykxy(uhvcfbnwhh) = ulmgnphame sdoajaoxfh (byyvoetdcs )
Positive
11 Dec 2023
(≥triple-class refractory)
xydnaeykxy(uhvcfbnwhh) = uslmlryhlc sdoajaoxfh (byyvoetdcs )
Not Applicable
1,926
BCMA-directed BsAbs
uqjbtcvsdj(tbfeyingop) = zffketlfja kkqgorywbv (rqvencueqb )
-
09 Dec 2023
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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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