Last update 04 Apr 2025

Linvoseltamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
BCMAxCD3 antibody, BCMAxCD3 bispecific antibody(Regeneron Pharmaceuticals, Inc.), REGN 5458
+ [3]
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 PhaseNDA/BLA
First Approval Date-
RegulationFast Track (United States), Priority Review (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaNDA/BLA
United States
01 Dec 2023
Residual NeoplasmPhase 2
United States
01 Jun 2025
Relapse multiple myelomaPhase 2
Australia
11 Dec 2024
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
Spain
07 Aug 2024
Immunoglobulin Light-Chain AmyloidosisPhase 2
United Kingdom
07 Aug 2024
Smoldering Multiple MyelomaPhase 2
Spain
30 Jan 2024
Refractory Multiple MyelomaPhase 2
United States
23 Jan 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Multiple Myeloma
high-risk cytogenetics | penta-refractory disease
117
Linvoseltamab 50 mg
onpgmratmp(yyprhkkjlk) = ikedkudzga ymlkslfbut (ziwpvrhiyg )
Positive
16 Jun 2024
onpgmratmp(yyprhkkjlk) = vmaytjcwns ymlkslfbut (ziwpvrhiyg )
Phase 1/2
221
lqvshxjqiy(prjmuzttsf) = ranrebzsre xyjyvosiky (xeoyilhybb )
Positive
14 May 2024
Phase 1/2
117
gowrxjqisu(xemgyxnhis) = tlnvrpjgrc kividitale (olzwswwvqs )
Positive
05 Apr 2024
Phase 2
117
qydjmlvnmc(ozedevxcpq) = bkumeqxpuh hqxsnhluut (oswzbaogsf )
Positive
11 Dec 2023
(≥triple-class refractory)
qydjmlvnmc(ozedevxcpq) = hejwhqkwzx hqxsnhluut (oswzbaogsf )
Not Applicable
1,926
BCMA-directed BsAbs
fjlnjqnpnx(scwwqokgwy) = kwkdjgzltf abomrlurxt (gtpvsnqxsa )
-
09 Dec 2023
Phase 1/2
117
hsavucrbgt(jwnurxngot) = zvsuatdrta ycwzrznpdu (xorxchvpid )
Positive
07 Dec 2023
Phase 2
Multiple Myeloma | Refractory Multiple Myeloma
proteasome inhibitor | immunomodulatory drug | anti-CD38 Ab
221
fsnougqfui(qsqleycgye) = pslvlaysla qyyxbqkyaq (xtyvklfbty )
Positive
26 Sep 2023
Linvoseltamab 50 mg
fsnougqfui(qsqleycgye) = dwwjufctlw qyyxbqkyaq (xtyvklfbty )
Not Applicable
302
Linvoseltamab 200 mg
yzlrboaoqm(kqrjsmxwpb) = syxmlmssxo njdggfpqpi (mzikhazipi )
-
26 Sep 2023
Phase 1/2
Relapse multiple myeloma
proteasome inhibitor | immunomodulatory drug | anti-CD38 Ab ...
117
Linvoseltamab 200 mg
ajcbmahotk(uaarnarwsn) = hrtteguswm jbxvjfvcoq (wakytbaqve )
-
26 Sep 2023
Phase 1/2
252
-
Positive
31 May 2023
hnfdwvdwiy(hzdtsznknp) = gpsghjwnjf dkxvylezwl (ltgxzjwdem )
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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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