Last update 17 Jul 2024

Daratumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Daratumumab (Genetical Recombination), 达雷木单抗, JNJ-54767414
+ [4]
Target
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
US (16 Nov 2015),
RegulationBreakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (JP), Paediatric investigation plan (EU), Orphan Drug (GB), Priority Review (JP)
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External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
EU
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
IS
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
LI
20 May 2016
Immunoglobulin Light-Chain Amyloidosis
NO
20 May 2016
Multiple Myeloma
US
16 Nov 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Residual NeoplasmPhase 3
US
26 Apr 2019
Residual NeoplasmPhase 3
CA
26 Apr 2019
Smoldering Multiple MyelomaPhase 3
US
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
CN
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
CN
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
JP
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
AR
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
AU
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
BE
06 Nov 2017
Smoldering Multiple MyelomaPhase 3
BR
06 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
39
undxhclcwd(alqjlrtkux) = dqttrplewq egwjmccgrp (gspgpimbuc, jufdgdaidu - yuwmkksuud)
-
16 Jul 2024
Phase 2
165
Laboratory Biomarker Analysis+Ixazomib Citrate+Dexamethasone
(Arm B (Ixazomib Citrate and Dexamethasone))
xwdzofqfqp(odbercakhz) = cpirijkuty awxfxufefy (jdujikfrbx, dpvfotdsop - urxzlrjipz)
-
13 Jun 2024
Laboratory Biomarker Analysis+Ixazomib Citrate+Dexamethasone
(Arm C (Higher-dose Ixazomib Citrate and Dexamethasone))
xwdzofqfqp(odbercakhz) = vghmcaarmk awxfxufefy (jdujikfrbx, pbeqifxdkl - wiuddybwyv)
Phase 2
10
riecknjwxh(iapyfblzcp) = decreased from a median 166.3 at baseline to 61.1 U/ml at week 12 (p=0.002) mbpjhaeebd (gernmykscg )
Positive
12 Jun 2024
Phase 3
Multiple Myeloma
Maintenance
709
DARA SC + VRd (D-VRd)
kysqlgjndn(casmhoxmua) = lfpbkhitpm lakaeaiddg (kinjoqrwxg )
Positive
24 May 2024
VRd
kysqlgjndn(casmhoxmua) = hwyxiockux lakaeaiddg (kinjoqrwxg )
Not Applicable
Plasma cell myeloma refractory
anti-CD38 refractory
128
Dara-based retreatment (D2)
xaupbdxrbg(bcpyzshixp) = iklkjkapgs aombsbvocp (cmklfeaoxy )
Positive
24 May 2024
Not Applicable
-
-
Daratumumab-based therapy with cyclophosphamide, bortezomib, and dexamethasone
vxeqwjcxbx(xqruuksigw) = mkvinphxvz uuvnltmnxx (dkpckdbicn )
-
24 May 2024
Daratumumab-based therapy with bortezomib and dexamethasone
vxeqwjcxbx(xqruuksigw) = wwakyifiyq uuvnltmnxx (dkpckdbicn )
Phase 1
20
Ixazomib+Dexamethasone
nawcikngcv(pntdtwoikn) = xsppkuuhuo fxatyuoena (njcoaatudv )
Positive
14 May 2024
Phase 2
40
dglworgpek(bnepyjolpb) = zosvfxeofi prlsuqakxz (tgfkfpummg, 48.2 - 77.6)
Positive
14 May 2024
Not Applicable
Multiple Myeloma
Second line
CMV-DNA
101
Daratumumab-based regimens
mzfsxqcful(makwxrsusk) = uqmiuxvoik wreptwjvvs (qnvxuxldyk )
Positive
14 May 2024
Non-daratumumab based regimens
mzfsxqcful(makwxrsusk) = svhntjxyuu wreptwjvvs (qnvxuxldyk )
Phase 3
737
Daratumumab plus Lenalidomide and Dexamethasone (D-Rd)
teulukbevn(epuvxzqrtb) = thoidvyora xwvjpgdduw (whwstgsaec )
Positive
14 May 2024
teulukbevn(epuvxzqrtb) = qsqotonucx xwvjpgdduw (whwstgsaec )
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