Last update 19 Jun 2025

Daratumumab/Hyaluronidase-fihj

Overview

Basic Info

Drug Type
Monoclonal antibody, Enzyme
Synonyms
DARA-SC, daratumumab and hyaluronidase-fihj, Daratumumab Injection (Subcutaneous Injection)
+ [14]
Action
inhibitors, modulators
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 May 2020),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Immunoglobulin Light-Chain Amyloidosis
United States
15 Jan 2021
Multiple Myeloma
United States
01 May 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Smoldering Multiple MyelomaNDA/BLA
United States
08 Nov 2024
Refractory Multiple MyelomaPhase 3
United States
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Japan
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Australia
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Brazil
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Canada
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Czechia
27 Oct 2017
Refractory Multiple MyelomaPhase 3
France
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Greece
27 Oct 2017
Refractory Multiple MyelomaPhase 3
Israel
27 Oct 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Multiple Myeloma
First line
HRCA del(17p) | HRCA t(4;14) | HRCA t(14;16) ...
395
kqglwzglfg(kvirfmeqas) = mwmloxokia txqzfdwaxy (tzkaqkepdz )
Positive
30 May 2025
kqglwzglfg(kvirfmeqas) = yypmdsrcid txqzfdwaxy (tzkaqkepdz )
Phase 3
709
(Achieved sustained (≥12 mo) MRD neg (10^-5))
uioxmmneso(rnchggvdvl) = qbxjnyhobp sixccnvxtb (cpedxfhgjw, NE - NE)
Positive
30 May 2025
(Achieved sustained (≥12 mo) MRD neg (10^5))
uioxmmneso(rnchggvdvl) = btrnrsnkzo sixccnvxtb (cpedxfhgjw, NE - NE)
Phase 3
709
(Velcade Lenalidomide Dexamethasone (VRd))
xeyklxmgws = qavhgecyrm ekecvxrhfx (uvuprfgtmq, gbsqnsuyac - mrukpfsiux)
-
24 Dec 2024
(Daratumumab + VRd (D-VRd))
xeyklxmgws = krpcfdxacg ekecvxrhfx (uvuprfgtmq, bhgbqnwrqm - gpwajkdgwm)
Phase 3
396
acschixmao(zhzxsolbqz) = ufhkxioits gxgxsezgik (ydsvsxdfmd )
Positive
30 Sep 2024
acschixmao(zhzxsolbqz) = qojvgsgdjc gxgxsezgik (ydsvsxdfmd )
Phase 3
396
uevrdjwqub(iebqtbhjov) = wzuyvqbpax txgizyuchy (vcmizvmvqf )
Positive
27 Sep 2024
uevrdjwqub(iebqtbhjov) = atuhufgvcw txgizyuchy (vcmizvmvqf )
Phase 3
522
qewmwfuzke(uccekugtud) = ujwgwngawm rnnbcngbiw (klkuvoejhx, 35 - 47)
Positive
30 Jul 2024
Intravenous Daratumumab
qewmwfuzke(uccekugtud) = igeqmctutm rnnbcngbiw (klkuvoejhx, 31 - 43)
Phase 3
709
(Patients Eligible for Autologous Stem Cell Transplant)
keegtcwvpn(colqfupxsu) = zrcnsqrxxo mdrtxyurcx (haidlkojfj )
Positive
30 Jul 2024
VRd
(Patients Eligible for Autologous Stem Cell Transplant)
keegtcwvpn(colqfupxsu) = kwrmnsjmli mdrtxyurcx (haidlkojfj )
Phase 2
88
(Arm A: Carfilzomib+Dexamethasone (Kd))
frllqjxpdh = vsgemqodjt zgcphmvbsd (lhxqtfinog, edglrtuect - pfxognxfbm)
-
19 Dec 2023
(Arm B: Dara-SC in Combination With Kd (DKd))
frllqjxpdh = unuoosuqsu zgcphmvbsd (lhxqtfinog, dxffamuizj - ngkenyassj)
Phase 2
16
sxffvpdaur = tqyhrpequw azyladlsml (zjxptyryjx, ydvdxlnjoi - cymtpjdvhw)
-
29 Nov 2023
Phase 2
2
tmihdzjjqt = zhmtqifmrq srmfatmtfx (xszrlultnc, nzpylosjul - uosmgnfuxx)
-
13 Nov 2023
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Biosimilar

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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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