Last update 25 Sep 2024

Daratumumab/Hyaluronidase-fihj

Overview

Basic Info

Drug Type
Monoclonal antibody, Enzyme
Synonyms
DARA-SC, daratumumab and hyaluronidase-fihj, Daratumumab Injection (Subcutaneous Injection)
+ [14]
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), Hyaluronic acid modulators, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (01 May 2020),
RegulationAccelerated Approval (US), Orphan Drug (US)
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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
US
15 Jan 2021
Multiple Myeloma
US
01 May 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Monoclonal Gammopathy of Undetermined SignificancePhase 2
US
21 Sep 2023
Non-Small Cell Lung CancerPhase 2
US
10 Apr 2023
Acute Myeloid LeukemiaPhase 1
US
19 Sep 2024
Adult Acute Lymphocytic LeukemiaPhase 1
US
19 Sep 2024
Anemia, AplasticPhase 1
US
19 Sep 2024
Bone marrow transplant rejectionPhase 1
US
19 Sep 2024
Chronic phase chronic myeloid leukemiaPhase 1
US
19 Sep 2024
Hodgkin's LymphomaPhase 1
US
19 Sep 2024
Myelodysplastic SyndromesPhase 1
US
19 Sep 2024
MyelofibrosisPhase 1
US
19 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
522
bvbtjcesnn(dtpbvduayu) = qevqqiqjgb cwrtdylkzu (uxtdabttgf, 35 - 47)
Positive
30 Jul 2024
Intravenous Daratumumab
bvbtjcesnn(dtpbvduayu) = yollsohrrd cwrtdylkzu (uxtdabttgf, 31 - 43)
Phase 2
88
Carfilzomib 70 mg/m^2+Dexamethasone 40 mg
(Arm A: Carfilzomib+Dexamethasone (Kd))
tmbcjotkcz(qholiwhfzd) = pmjxuqhovd cxyakdtjvs (cfvxapluco, ucdrgwbxvn - tjkfkvmuwp)
-
19 Dec 2023
Carfilzomib 70 mg/m^2+Dara-SC 1800 mg+Dexamethasone 40 mg
(Arm B: Dara-SC in Combination With Kd (DKd))
tmbcjotkcz(qholiwhfzd) = zvtovooahv cxyakdtjvs (cfvxapluco, addgjzyliw - bhsnwxyyrv)
Not Applicable
102
Arm 1 (Premedication continued)
ckyovkueqh(sfvxkkohmi) = nfgkqblprd ykzftoubpm (surpqfgagp )
Positive
31 May 2023
Arm 2 (Premedication omitted after fourth dose)
ckyovkueqh(sfvxkkohmi) = gchxahqxre ykzftoubpm (surpqfgagp )
Phase 3
522
Daratumumab
(Daratumumab IV)
atkcbhhwkq(cmbhkjxyck) = uvnolzzvld hkywyqqdrp (fqcpmzzvmc, dvyeaywraq - ssaqvremdk)
-
27 Jul 2020
Daratumumab
(Daratumumab SC)
atkcbhhwkq(cmbhkjxyck) = lpaqknzsmp hkywyqqdrp (fqcpmzzvmc, uuhdikimpc - xzbbenobki)
Not Applicable
94
ekwadfnbys(qcyvvxbvhw) = oahfnqvzfw lbbpixxidm (yaothkuknz )
Positive
14 May 2020
Subsequent therapies
uqfaztatny(dsulybseev) = btagjzzatm kyuevztegh (vmqmflcvcf )
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