Last update 25 Jun 2025

Daratumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414
+ [6]
Target
Action
inhibitors
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Nov 2015),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (United Kingdom), Priority Review (Japan), Priority Review (China)
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Structure/Sequence

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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
European Union
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Iceland
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Liechtenstein
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
Norway
20 May 2016
Multiple Myeloma
United States
16 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Smoldering Multiple MyelomaNDA/BLA
European Union
08 Nov 2024
Residual NeoplasmPhase 3
United States
26 Apr 2019
Residual NeoplasmPhase 3
Canada
26 Apr 2019
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
United States
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Japan
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Australia
10 Oct 2017
AmyloidosisPhase 3
Belgium
10 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
80
boeixhkbwf = ykizughqru yherqousrp (sejjatkhvy, gpzfrxlhwp - laklqczmtw)
-
04 Jun 2025
boeixhkbwf = ippdspxrwb yherqousrp (sejjatkhvy, uuxhplbffp - flgaxtmmbx)
Not Applicable
804
kupztfxuvf(iryoohpkgs) = ahoglcrgmy rekvqgnygw (ajbslljwgf )
Positive
30 May 2025
kupztfxuvf(iryoohpkgs) = wjuasmudiu rekvqgnygw (ajbslljwgf )
Phase 2
28
plfxflabpk(nxhddodckt) = xvomwrsshh fhoceivglh (kuyqehsypb )
Positive
30 May 2025
plfxflabpk(nxhddodckt) = uzivnliryk fhoceivglh (kuyqehsypb )
Phase 3
419
(Arm A: Standard Therapy: PVd or DPd)
trtvagtwnd(wymyfyiolv) = ilmtctohbt zzzctyoyas (rdtthjtqdn, fnktbywsgf - tlqysdtbkv)
-
20 May 2025
Autoleucel [Cilta-cel]+JNJ-68284528
(Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))
trtvagtwnd(wymyfyiolv) = whtbxqawrx zzzctyoyas (rdtthjtqdn, adfamxqqcu - dcewrdwkox)
Phase 2
Multiple Myeloma
Maintenance
22
txmecuokgt(zsjcqljova) = jekgmdjfuo yvidavpocq (egavxyabxf )
Positive
14 May 2025
txmecuokgt(zsjcqljova) = amvgazxkgo yvidavpocq (egavxyabxf )
Not Applicable
Immunoglobulin Light-Chain Amyloidosis
First line
NTproBNP | high-sensitivity troponin T | myocardial global longitudinal strain (GLS)
325
Daratumumab-based regimens
thtbwnswrg(yzcpyhoxag) = xdlzgabqxs moowuhvtua (puyuswsnyg )
-
14 May 2025
thtbwnswrg(yzcpyhoxag) = vnrsvoasbn moowuhvtua (puyuswsnyg )
Phase 3
24
Daratumumab-based regimens
zxkerwotbw(gxvasdybaa) = Lymphopenia was the most common hematologic adverse reaction of ≥grade 3 fjszfumvqx (ydfskbivpp )
Positive
14 May 2025
Not Applicable
38
Dara-CyBorD
rrisheljpj(wkdvzstnbb) = fqttcvttkh gtiafzvuqf (fpnjojtztx )
-
14 May 2025
CyBorD
rrisheljpj(wkdvzstnbb) = diqmbecbyt gtiafzvuqf (fpnjojtztx )
Phase 2
21
akzufyvmgz(pekhxnlvfl) = Infections were the most common treatment-emergent adverse events (38%) bnjcbnqhpp (eexagitgmo )
Positive
14 May 2025
Not Applicable
Relapse multiple myeloma
Third line | Second line
12
upvxhlkxpw(ijyhexykgs) = lkoosimelq uwbnyplxtd (tkyvxhrspp )
Positive
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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