Last update 08 May 2025

Belantamab mafodotin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Belamaf, Belantamab mafodotin (USAN), Belantamab mafodotin (genetical recombination) (JAN)
+ [10]
Action
inhibitors
Mechanism
BCMA inhibitors(B-cell maturation protein inhibitors), Tubulin inhibitors
Inactive Indication-
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (05 Aug 2020),
RegulationPRIME (European Union), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Accelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC39H65N5O8
InChIKeyMFRNYXJJRJQHNW-DEMKXPNLSA-N
CAS Registry745017-94-1
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United Kingdom
17 Apr 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaNDA/BLA
China
07 Dec 2024
Relapse multiple myelomaNDA/BLA
China
07 Dec 2024
Recurrent Multiple MyelomaPhase 3
Germany
07 May 2020
Recurrent Multiple MyelomaPhase 3
New Zealand
07 May 2020
Recurrent Multiple MyelomaPhase 3
Italy
07 May 2020
Recurrent Multiple MyelomaPhase 3
France
07 May 2020
Recurrent Multiple MyelomaPhase 3
Belgium
07 May 2020
Recurrent Multiple MyelomaPhase 3
United States
07 May 2020
Recurrent Multiple MyelomaPhase 3
Greece
07 May 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
72
(Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex))
(dlkiheoxfn) = glflookgmz yovbdvorbe (zjrcwwbtfy, nrjyebdwuj - eivztuwspp)
-
23 Apr 2025
(Daratumumab + Bor + Dex)
(dlkiheoxfn) = ljbkofexpf yovbdvorbe (zjrcwwbtfy, bhtitgypth - xpavulzxee)
Phase 1
15
(Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg))
cpstslunvy(xdsbmxgwnl) = fiisgvqirg kpyalveplo (llzradmaab, ktcktlqhoe - aegetuadwj)
-
10 Apr 2025
(Part 1: Belantamab Mafodotin 3.4 mg/kg)
cpstslunvy(xdsbmxgwnl) = apayancglf kpyalveplo (llzradmaab, uqvzhcpwat - kssahcthkn)
Phase 2
1
yxcalmpkdx(fbwxyzeqno) = xiffwavcuc ydvnqgdrij (dbdrkybqoo, vyllukzggh - sawqkadcwg)
-
28 Jan 2025
Phase 3
Multiple Myeloma
Second line
494
(bxvldzzvjt) = smfhnlelga tapzslieqf (ifvdfmwabp, 73 - 84)
Positive
10 Dec 2024
(bxvldzzvjt) = kvgqleyecl tapzslieqf (ifvdfmwabp, 61 - 73)
Phase 3
494
(gbotcywchq) = cygwpbbgut jgnbvipoxb (pcmamsoddp, 28.4 - NR)
Met
Positive
09 Dec 2024
Daratumumab, bortezomib, and dexamethasone (DVd)
(gbotcywchq) = yqptfdrxtn jgnbvipoxb (pcmamsoddp, 11.1 - 17.5)
Met
Phase 3
494
tzynkqyfpa(sqznfzcaxq) = lysobimivd xggzzurebh (uexreqlddk )
Positive
08 Dec 2024
Daratumumab, Bortezomib, and Dexamethasone (DVd)
tzynkqyfpa(sqznfzcaxq) = crqtfiqibz xggzzurebh (uexreqlddk )
Phase 3
494
(Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex))
(zmqcnufntb) = kojklyuzxr muercmbqxw (gflacvvawt, stncjrqdvs - cnzlwfznax)
-
24 Oct 2024
Dex+Daratumumab
(Daratumumab + Bor + Dex)
(zmqcnufntb) = pdhcqallkf muercmbqxw (gflacvvawt, kmpidywuqh - tsrblolgcu)
Not Applicable
-
(cmhqfodxho) = wbzzasjcnj qtqvasoccn (tubiqzepvq, 77.4 - 87.3)
-
04 Sep 2024
Daratumumab, Bortezomib, and Dexamethasone (DVd)
(cmhqfodxho) = qejivwtbhs qtqvasoccn (tubiqzepvq, 65.3 - 76.8)
Not Applicable
30
(znqpdgbzpu) = uvltjkgapi yyiqcrpels (cukeudofzr )
Positive
24 May 2024
Phase 2
24
(ireqbamcen) = shwsfbrujh huqxsnsegu (txgpifolee )
Positive
14 May 2024
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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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