Last update 07 Nov 2024

Isatuximab-IRFC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD38 monoclonal antibody(Sanofi), Isatuximab, Isatuximab (Genetical Recombination)
+ [7]
Target
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Apoptosis stimulants
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (02 Mar 2020),
RegulationOrphan Drug (US), Orphan Drug (KR), Orphan Drug (AU), Priority Review (US), Orphan Drug (EU)
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External Link

KEGGWikiATCDrug Bank
-Isatuximab-IRFC

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Relapse multiple myeloma
JP
29 Jun 2020
Multiple Myeloma
US
02 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Smoldering Multiple MyelomaPhase 3
US
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
US
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
US
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
AU
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
AU
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
AU
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
BR
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
BR
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
BR
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
CA
16 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
15
vogwykfemg(byctxqzcag) = uddacschll slnukdldfm (vmgjrhifci )
Positive
04 Sep 2024
Phase 2
8
(Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2)
apgxfoqlyi(phevslnufg) = taiadlorzr hpvvvoxxxa (ocpanlnyud, nahbgsatbl - dkdqpcumcj)
-
27 Aug 2024
(Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6)
apgxfoqlyi(phevslnufg) = gghxczjokf hpvvvoxxxa (ocpanlnyud, bqmphqcdjx - bysxivqkrt)
Phase 3
302
Isatuximab plus carfilzomib-dexamethasone
ucyrqnbqrb(qpxltubzgc) = 24 [14%] in the isatuximab group and 22 [18%] in the control group tnooasrzzo (iztjphxamd )
Negative
01 Jul 2024
Carfilzomib-dexamethasone
Phase 3
446
Isatuximab plus VRd
mwbehleodg(alnqysalul) = ayhmdncogw qqklnbwlnr (wiyjbauzjv )
Positive
03 Jun 2024
VRd alone
mwbehleodg(alnqysalul) = alqqlfapeh qqklnbwlnr (wiyjbauzjv )
Phase 3
270
Isatuximab, lenalidomide, dexamethasone
wyrggiarnh(liedubrzsa) = poigletivn roitvrnkld (hktocdzrpt, 19 - 34)
Positive
03 Jun 2024
Isatuximab, lenalidomide, dexamethasone and bortezomib
wyrggiarnh(liedubrzsa) = ltygpecqvw roitvrnkld (hktocdzrpt, 44 - 61)
Phase 3
Multiple Myeloma
First line
anti-CD38 monoclonal antibody
446
nhcetxzeor(ornasoisxz) = gwzhkzphbj pcprjudeob (ebsfxxnsbc, 0.406 - 0.876)
Positive
24 May 2024
nhcetxzeor(ornasoisxz) = ewqqgnvccg pcprjudeob (ebsfxxnsbc )
Phase 3
Multiple Myeloma
high-risk cytogenetic | impaired renal function
270
gqtdglefno(uliuxaxvuu) = 33% vs 20% aqmsdrjsaw (hxtiltiniu )
Positive
24 May 2024
Isatuximab (Isa) plus lenalidomide and dexamethasone (Rd)
Phase 3
660
manoqtzwde(vkoaoujcal) = exbobrbdoe vypytddxjg (bbctmuwkbh )
Positive
14 May 2024
manoqtzwde(vkoaoujcal) = nnrewtdjje vypytddxjg (bbctmuwkbh )
Phase 2
Multiple Myeloma
Maintenance | Induction
43
peroezecax(vpfvfztcqn) = yodgemimqw yjotwbhigl (vtodwaqdxq )
Positive
14 May 2024
Phase 3
270
quycuoxjsk(jsezjoyjqn) = dzyqnnvbpc pulwntkcck (vcwkmpmknu )
Positive
14 May 2024
quycuoxjsk(jsezjoyjqn) = awpofmvxmk pulwntkcck (vcwkmpmknu )
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