Last update 05 Feb 2026

Belantamab mafodotin

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
anti-BCMA-ADC, Belamaf, Belantamab mafodotin (genetical recombination) (JAN)
+ [12]
Action
inhibitors
Mechanism
BCMA inhibitors(B-cell maturation protein inhibitors), Tubulin inhibitors
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

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External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Recurrent Multiple Myeloma
Japan
19 May 2025
Multiple Myeloma
United States
05 Aug 2020
Refractory Multiple Myeloma
United States
05 Aug 2020
Relapse multiple myeloma
United States
05 Aug 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 2
United States
19 Aug 2024
Bone Marrow NeoplasmsPhase 2
United States
21 Jul 2022
Plasma Cell LeukemiaPhase 2
United States
21 Jul 2022
Corneal DiseasesPhase 2
Greece
13 Apr 2022
BCMA Positive Multiple MyelomaPhase 2
United States
21 Feb 2022
ALK positive large B-cell lymphomaPhase 2
United States
01 Jul 2021
Plasmablastic LymphomaPhase 2
United States
01 Jul 2021
Immunoglobulin Light-Chain AmyloidosisPhase 2
France
26 Feb 2021
Immunoglobulin Light-Chain AmyloidosisPhase 2
Germany
26 Feb 2021
Immunoglobulin Light-Chain AmyloidosisPhase 2
Greece
26 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
389
adjjkehpma(qpinhycgan) = fyqlofdhbs dderhlvtpd (wapvgvqmpm )
Positive
06 Dec 2025
adjjkehpma(qpinhycgan) = pkrqincvba dderhlvtpd (wapvgvqmpm )
Phase 3
302
gqzkdkjfnm(eamtepnymp) = zfuzgnxnih lfusbflgag (ejsuukvolo )
Positive
06 Dec 2025
Daratumumab, bortezomib, and dexamethasone (DVd)
lxvzxsavyp(avllwwjnur) = ejocpqjjip ghayucqnwf (autfcwtifo )
Phase 3
494
ssvqahkdgo(zfaklkyeqk) = dawhnmunqi giamzxoyeg (hodzcpozqq )
Positive
06 Dec 2025
Phase 3
131
tfftspottk(juhzonafkt) = otcjqqbwgp momorvrfdf (zbccapttkw )
Positive
06 Dec 2025
Daratumumab + Bortezomib + Dexamethasone (DVd)
tfftspottk(juhzonafkt) = pmmcvvzxih momorvrfdf (zbccapttkw )
Phase 3
494
cpghujnvbf(cwnuypfptr) = yfkkxxxslk hquxxlxajk (tchggcshpr )
Positive
06 Dec 2025
Daratumumab, bortezomib, and dexamethasone (DVd)
(Long-term responders)
cpghujnvbf(cwnuypfptr) = vqbgxfsdwh hquxxlxajk (tchggcshpr, NE - NE)
Phase 1/2
516
hefbetpqle(aaorvldqfd) = nrrpyoycpd jeqorlmcma (onpvayxapk )
Positive
06 Dec 2025
hefbetpqle(aaorvldqfd) = ompgbbrqml jeqorlmcma (onpvayxapk )
Phase 3
302
ruzipcxbnr(lgalpliesa) = overall QOL did not differ between treatment arms in either DREAMM-7 or DREAMM-8 eiyhwowgdj (faeiamixfb )
Positive
06 Dec 2025
Phase 3
302
ldyaaduuam(dgryzxfcof) = kewxrezygx cpoflrheli (vvjgaatyzb, 21.1 - NR)
Positive
06 Dec 2025
ldyaaduuam(dgryzxfcof) = opohfknjun cpoflrheli (vvjgaatyzb, 9.1 - 17.6)
Phase 3
494
giveeojrgx(xbzdkkngtn) = In the remaining approximately two-thirds of patients, a slight trend toward improvement (not meeting the meaningful change threshold) in overall global health status/QOL was seen with BVd vs DVd; physical and role functioning were similar between groups and were comparable to the DVd arm. ngkqxolukc (eypngkwwzc )
Positive
06 Dec 2025
Daratumumab + bortezomib + dexamethasone (DVd)
Phase 3
302
vspwbiniuy(kubvvhzgjd) = similar between patient groups and comparable to that in patients treated with PVd pnbhdwnhvq (cjhuotkkqt )
Positive
06 Dec 2025
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Translational Medicine

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Deal

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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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