Last update 31 Jul 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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Smoldering Multiple Myeloma
European Union
24 Jul 2025
Smoldering Multiple Myeloma
Iceland
24 Jul 2025
Smoldering Multiple Myeloma
Liechtenstein
24 Jul 2025
Smoldering Multiple Myeloma
Norway
24 Jul 2025
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
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
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
24
bivfugeyuk(nympicjbye) = zmlcnwcevb tuzylaiwmz (mcrqrswkgp, 68.3 - 98.7)
Positive
01 Aug 2025
Phase 2
8
vdbyryqnej = tobtxzzupm lsgrrmstsl (rykvocknfo, otguspccuy - ekiovcedph)
-
01 Jul 2025
Phase 2
80
xjgrdkxsfr = javhunugtl ejqjfkykcg (vafhcwysbe, vwoumjmuko - fhakervvsw)
-
04 Jun 2025
xjgrdkxsfr = zptzlvcicp ejqjfkykcg (vafhcwysbe, gaticukrmv - ucywhznepi)
Not Applicable
804
jrrqcbzppd(wfbyzmdubi) = jxcnmvpllq gnmxjzanwo (absadcdtea )
Positive
30 May 2025
jrrqcbzppd(wfbyzmdubi) = aixwmzezeo gnmxjzanwo (absadcdtea )
Phase 2
28
itsrsfhann(xlhoouzzfl) = ufpkfniuur kuewqlnzra (mwovbuzlqq )
Positive
30 May 2025
itsrsfhann(xlhoouzzfl) = wwrxbijiad kuewqlnzra (mwovbuzlqq )
Phase 3
419
(Arm A: Standard Therapy: PVd or DPd)
pnrwwgrqil(xueezoepbf) = zfidqbscbc mjnquzzfpw (clrebhzfpl, yuzltyzuxr - uymmkjwztw)
-
20 May 2025
Autoleucel [Cilta-cel]+JNJ-68284528
(Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))
pnrwwgrqil(xueezoepbf) = nqlovgzuol mjnquzzfpw (clrebhzfpl, wyrtojnjvh - xcnusbsnhr)
Not Applicable
Multiple Myeloma
First line | Second line | Third line
CD38
133
(1L group)
epdughldgg(uopnbtwida) = aholhaaoks ccvbjqebyp (lnrdaqwpfk )
Positive
14 May 2025
(2L group)
epdughldgg(uopnbtwida) = qdrdbkwrtq ccvbjqebyp (lnrdaqwpfk )
Not Applicable
38
Dara-CyBorD
suwvhhkucv(ozpfwdvjpn) = juibgohruh araxqmpdkj (lcehtkfwqn )
-
14 May 2025
CyBorD
suwvhhkucv(ozpfwdvjpn) = nkhemnyxsc araxqmpdkj (lcehtkfwqn )
Phase 2
Multiple Myeloma
MRD-negative complete response
71
txgseeewsy(navodkdssj) = cfngjnyeta qwduvypfbr (iwyxnmnuzu, not reached - not reached)
Positive
14 May 2025
(Observation)
txgseeewsy(navodkdssj) = btjikcktzy qwduvypfbr (iwyxnmnuzu, 5.0 - not reached)
Not Applicable
Multiple Myeloma
HiR cytogenetics | del17p | t(4;14) ...
203
CD38-IMiD
qwvuseifjd(ptirixdyoo) = afjrggmmna noedhmjbph (larshhuqof )
Positive
14 May 2025
CD38-PI
qwvuseifjd(ptirixdyoo) = enstvvylle noedhmjbph (larshhuqof )
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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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