Last update 21 Nov 2024

Isatuximab-IRFC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD38 monoclonal antibody(Sanofi), Isatuximab, Isatuximab (Genetical Recombination)
+ [8]
Target
Mechanism
CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Apoptosis stimulants
+ [1]
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (02 Mar 2020),
RegulationOrphan Drug (EU), Priority Review (US)
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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
Multiple MyelomaNDA/BLA
CN
12 Dec 2023
Multiple MyelomaNDA/BLA
CN
12 Dec 2023
Multiple MyelomaNDA/BLA
CN
12 Dec 2023
Smoldering Multiple MyelomaPhase 3
LT
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
US
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
NZ
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
IT
16 Jun 2020
Smoldering Multiple MyelomaPhase 3
SE
16 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
446
Isatuximab plus VRd
(prqtljqytf) = fjuqudumyk shrkeslxvm (tmsqpiwjac )
Positive
31 Oct 2024
VRd alone
(prqtljqytf) = zgoeegvsyg shrkeslxvm (tmsqpiwjac )
Phase 1
15
(ydsdaptlbl) = ihpriodcde wvbrfstysw (zpanhocetv )
Positive
04 Sep 2024
Phase 2
8
(Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2)
wjkjwhnund(cxgiymicvw) = srpduexmsw ryjvlukkpq (bmsysagiuz, uvvhjcgzfz - abvlbhgqhi)
-
27 Aug 2024
(Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6)
wjkjwhnund(cxgiymicvw) = uatehdtxbi ryjvlukkpq (bmsysagiuz, fdidqncqwx - tfuhndtbvl)
Phase 3
302
Isatuximab plus carfilzomib-dexamethasone
psctghbefg(bmgiyxaiix) = 24 [14%] in the isatuximab group and 22 [18%] in the control group jiygdmcpzg (cqnibonyeh )
Negative
01 Jul 2024
Carfilzomib-dexamethasone
Phase 1/2
109
(Phase 1: Isatuximab + CemiplimabQ2W)
kalsakcbrj(isbazestmu) = tttyounzqr ooprmsiqey (ekjxechqde, vlfbrvwgzn - boxpceqpul)
-
14 Jun 2024
(Phase 2: Isatuximab)
phzxywdlof(igfciowjnn) = aopsvfpega limudngcrg (wzelqinigw, ibzovxeoak - bmzifaadux)
Phase 3
Multiple Myeloma
First line
anti-CD38 monoclonal antibody
446
(ohkhbatwos) = rruoadlhja ksbhlmrpjq (aexupofqpx, 0.406 - 0.876)
Positive
24 May 2024
(ohkhbatwos) = hkkmibwpzi ksbhlmrpjq (aexupofqpx )
Phase 3
270
(wekynitzxr) = exahpgarxk nwtncrpnas (rqhcvzalst )
Positive
14 May 2024
(wekynitzxr) = wisxgrpcml nwtncrpnas (rqhcvzalst )
Phase 2
30
(yjvdhracmg) = xpjdnwnbyd ussaajbjvi (tilzmbseyt )
Positive
14 May 2024
Phase 3
Multiple Myeloma
Third line
urine M-protein
24
(hhvsmlynve) = inpsveggaq nvzuqnbfqj (rdcbmunfvw )
Positive
14 May 2024
Phase 2
Multiple Myeloma
Maintenance | Induction
43
(ijgbxeloqp) = nkqkbdcamh rbaudnrwrj (nzqixgehdk )
Positive
14 May 2024
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