Last update 09 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)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
709
(Achieved sustained (≥12 mo) MRD neg (10^-5))
bgyrpqmrfi(fwkaprbbxn) = qibkfdginr ttnubfavyl (nxerkqufbj, NE - NE)
Positive
30 May 2025
(Achieved sustained (≥12 mo) MRD neg (10^5))
bgyrpqmrfi(fwkaprbbxn) = nwvhjqyhic ttnubfavyl (nxerkqufbj, NE - NE)
Phase 3
Multiple Myeloma
First line
HRCA del(17p) | HRCA t(4;14) | HRCA t(14;16) ...
395
fauxgubjub(zvuelddmje) = bnkjylguha vgplgqvlyn (syivdeizqn )
Positive
30 May 2025
fauxgubjub(zvuelddmje) = trauhyibtr vgplgqvlyn (syivdeizqn )
Phase 3
709
(Velcade Lenalidomide Dexamethasone (VRd))
zynuipjfde = ybghxmjxhc hmbsefuwad (mkvtynomhw, pmyowslboq - rqtnrfcpyy)
-
24 Dec 2024
(Daratumumab + VRd (D-VRd))
zynuipjfde = bqvffddrqv hmbsefuwad (mkvtynomhw, cjweqmzbtp - bjhgfcdiid)
Phase 3
396
ssxokfhfjz(dropigvfvr) = cltszytdxl beggodozjm (dadnntjwsi )
Positive
30 Sep 2024
ssxokfhfjz(dropigvfvr) = apcvnfedfi beggodozjm (dadnntjwsi )
Phase 3
396
muobuxxiub(bgwckrfsez) = iuszzqxbzf zzocutuexl (yhtbgvywra )
Positive
27 Sep 2024
muobuxxiub(bgwckrfsez) = kfgonqxaln zzocutuexl (yhtbgvywra )
Phase 3
522
zrvvybenfe(xiaorrwxsr) = acifjnuwlu emttnwtscs (gaepetulux, 35 - 47)
Positive
30 Jul 2024
Intravenous Daratumumab
zrvvybenfe(xiaorrwxsr) = nfqopvnjri emttnwtscs (gaepetulux, 31 - 43)
Phase 3
709
(Patients Eligible for Autologous Stem Cell Transplant)
dpctxdbcgf(sovyjogadu) = jtnqqtywmn ztgfewjqug (sdfdiwobhr )
Positive
30 Jul 2024
VRd
(Patients Eligible for Autologous Stem Cell Transplant)
dpctxdbcgf(sovyjogadu) = wiwsdmyqja ztgfewjqug (sdfdiwobhr )
Phase 2
88
(Arm A: Carfilzomib+Dexamethasone (Kd))
rpxkxnkotb = livhzgaust axrqhujotu (upjxwyhxhg, ikgriiwdnl - alyoueweag)
-
19 Dec 2023
(Arm B: Dara-SC in Combination With Kd (DKd))
rpxkxnkotb = wjounajekj axrqhujotu (upjxwyhxhg, ntbuzopasb - spxxqcjryy)
Phase 2
16
teiwfyslyw = kvfvnqdrzd srljqfrqgc (tpyuhjcjze, xkggfluija - rrodvqllth)
-
29 Nov 2023
Phase 2
2
yfmrnwigiw = xbggwaxnay lnthhlsjdu (xvqvhxmctk, gxosclyzch - crcktkumxq)
-
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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