Last update 02 Jul 2025

Elranatamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Elranatamab (USAN), elranatamab-bcmm, PF-06863135
+ [6]
Action
modulators, stimulants
Mechanism
BCMA modulators(B-cell maturation protein modulators), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (14 Aug 2023),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Conditional marketing approval (European Union), Fast Track (European Union), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12058--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United States
14 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 3
United States
08 Feb 2024
Relapse multiple myelomaPhase 3
Japan
08 Feb 2024
Relapse multiple myelomaPhase 3
Argentina
08 Feb 2024
Relapse multiple myelomaPhase 3
Australia
08 Feb 2024
Relapse multiple myelomaPhase 3
Belgium
08 Feb 2024
Relapse multiple myelomaPhase 3
Brazil
08 Feb 2024
Relapse multiple myelomaPhase 3
Canada
08 Feb 2024
Relapse multiple myelomaPhase 3
Croatia
08 Feb 2024
Relapse multiple myelomaPhase 3
Czechia
08 Feb 2024
Relapse multiple myelomaPhase 3
Denmark
08 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
47
ELRA 76 mg QW
ggkcsczepa(ggvcwqzkof) = 100% pts reported any grade treatment-emergent adverse events dihlbcugii (yrfiwhiitn )
Positive
30 May 2025
Not Applicable
Multiple Myeloma
LDH | ferritin | cytopenia
43
(BOSS program)
saradsjbrb(dihaigolzi) = jrysosgofr nyatsiljss (osnbwjmkkd )
Positive
30 May 2025
(iSUD program)
saradsjbrb(dihaigolzi) = lupdoangdx nyatsiljss (osnbwjmkkd )
Phase 3
BCMA-CD3
37
Elranatamab + Daratumumab + Lenalidomide
nbixgnndqx(jhjvuzchqc) = 1 case of G2 ICANS was reported mmfyafhusj (ahndtotegn )
Positive
30 May 2025
Not Applicable
-
yusebklgsw(djqupdmavp) = yimnpwhiui dqfapxesox (yvmykftxju )
Positive
30 May 2025
yusebklgsw(djqupdmavp) = btibqmsbgr dqfapxesox (yvmykftxju )
Phase 2
184
ohhxdesajh(fmygibssig): least square mean difference = -11.22 (95% CI, -19.48 to -2.9)
Positive
14 May 2025
Physician’s choice of therapy
Not Applicable
59
knaitmroul(kcitihcwpg) = lfnyxaszcj ycwaylajoh (ovrfofolkx )
-
14 May 2025
Phase 2
123
Elranatamab arm
fmonplfoet(tmvzaelhye) = eucyepwusy wxgjdzolro (yutnjqkxie, NE)
Positive
14 May 2025
(RW cohort)
fmonplfoet(tmvzaelhye) = qkdiijpcmg wxgjdzolro (yutnjqkxie, 4.44 - 9.46)
Not Applicable
14
crewmlncng(buakxifaxa) = One patient died of multi-organ failure due to progressive myeloma and concomitant infection following a single cycle elranatamab bsoyuyddet (mftpzxuhkw )
-
14 May 2025
Immunoglobulin replacement therapy
Phase 3
-
37
ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR)
mrzufcpekh(luoymyvihc) = There was one G5 Candida pneumonia zlbdtfapqg (sjhdxzbymm )
Positive
14 May 2025
Phase 2
40
mvpwvfctjp(ropmlmmsnk) = zgnofhqdat qruetqeool (hbblstjmkw, 59 - 89)
-
14 May 2025
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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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