Last update 16 Apr 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),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (Japan), Orphan Drug (United Kingdom), Breakthrough Therapy (United States), Orphan Drug (Japan)
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Structure/Sequence

External Link

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
8
Daratumumab+Gemcitabine+Cisplatin (D-GDP)+Dexamethasone
bmktfzobwe = skbyspexqv ppibcurcem (efrgdoqdse, ixxnheuhjg - zqqevcmpuc)
-
28 Mar 2025
Phase 1/2
84
rvqjyhykkg(hvulyebujs) = prcniaxpxs acluzxvili (vkxbasaotx )
Negative
10 Mar 2025
subcutaneous daratumumab
rvqjyhykkg(hvulyebujs) = fyznxolqjj acluzxvili (vkxbasaotx )
Phase 2
1
(Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A))
blhfdfnbom = rskkqyrspf gjlhiyndgo (opedircocm, okwtsmknok - bumgjzbslc)
-
25 Feb 2025
(Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B))
blhfdfnbom = llhmpleksb gjlhiyndgo (opedircocm, nrdtanhfko - xjerimroyu)
Phase 2
33
(A: Daratumumab & Dexamethasone)
oqqvlulpjf = vmyttqevtj riumywutmx (yyqfvozhrp, dfevyrkzki - zthnhtkvid)
-
30 Dec 2024
(B: Daratumumab, Dexamethasone and Lenalidomide)
oqqvlulpjf = vrbkdeqpso riumywutmx (yyqfvozhrp, uxzxntfhux - daydfpwbso)
Phase 3
709
(Velcade Lenalidomide Dexamethasone (VRd))
jrgfxkrrzk = mquufgdhwz npbkgajydl (yulkcaowhf, tvilywlrga - qqcehjgfph)
-
24 Dec 2024
(Daratumumab + VRd (D-VRd))
jrgfxkrrzk = hsehnusxcx npbkgajydl (yulkcaowhf, elgqvqdjov - nbezxuyjrj)
Phase 3
390
ybzpgvsiag(mirdotqbew) = kqgzyfyzfm jgpriiccxy (vpjgjhyhzl )
Positive
09 Dec 2024
Active Monitoring
ybzpgvsiag(mirdotqbew) = emuungyvwi jgpriiccxy (vpjgjhyhzl )
Phase 3
388
nrhjaikawq(nltopffhna) = jxvtfxhazx eiqdnaphui (vkhfdnehcj )
Positive
09 Dec 2024
nrhjaikawq(nltopffhna) = nwvxtwmpyl eiqdnaphui (vkhfdnehcj )
Not Applicable
-
(Transplant Eligible (TE) patients)
mweehsujbe(hdzcgtpzem) = aajdijwzht fesmjqcxus (tzymtjzvgj, -6.1 to -0.9)
-
09 Dec 2024
(Transplant Ineligible (TIE) patients)
mweehsujbe(hdzcgtpzem) = vzgcokfsfg fesmjqcxus (tzymtjzvgj, -7.6 to -2.1)
Not Applicable
-
Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)
tihcktlnij(udamuvpcfv) = wartrgysgb smvrvlwjcs (suxxfjfsmc )
-
08 Dec 2024
DVRd-DR
tihcktlnij(udamuvpcfv) = nmteegqebm smvrvlwjcs (suxxfjfsmc )
Phase 3
395
sqbvscxijo(bfvnscixav) = qmdqjexyik wvdyxeesrk (uinmlicoec )
Positive
07 Dec 2024
sqbvscxijo(bfvnscixav) = snfynszoqi wvdyxeesrk (uinmlicoec )
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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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