Last update 30 Mar 2025

Brexucabtagene Autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
brexu-cel, FKC-889, FKC889
+ [4]
Target
Action
modulators
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Priority Review (Canada), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pre B-cell acute lymphoblastic leukemia
Australia
30 Sep 2022
Mantle cell lymphoma recurrent
European Union
14 Dec 2020
Mantle cell lymphoma recurrent
Iceland
14 Dec 2020
Mantle cell lymphoma recurrent
Liechtenstein
14 Dec 2020
Mantle cell lymphoma recurrent
Norway
14 Dec 2020
Mantle cell lymphoma refractory
European Union
14 Dec 2020
Mantle cell lymphoma refractory
Iceland
14 Dec 2020
Mantle cell lymphoma refractory
Liechtenstein
14 Dec 2020
Mantle cell lymphoma refractory
Norway
14 Dec 2020
Acute Lymphoblastic Leukemia
United States
24 Jul 2020
Mantle-Cell Lymphoma
United States
24 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2
United States
26 Dec 2023
Burkitt LymphomaPhase 2
United States
01 Nov 2022
Burkitt LymphomaPhase 2
Austria
01 Nov 2022
Burkitt LymphomaPhase 2
France
01 Nov 2022
Burkitt LymphomaPhase 2
Germany
01 Nov 2022
Burkitt LymphomaPhase 2
Italy
01 Nov 2022
Burkitt LymphomaPhase 2
Netherlands
01 Nov 2022
Burkitt LymphomaPhase 2
Spain
01 Nov 2022
Burkitt LymphomaPhase 2
Switzerland
01 Nov 2022
Hairy Cell LeukemiaPhase 2
United States
01 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
95
ecmmnmzdtx(amuyjxhaqv) = thrcbtcpup marajwogjd (nvhbavogrp, 82.5 - 95.9)
Met
Positive
09 Dec 2024
Phase 2
74
Brexucabtagene Autoleucel (Brexu-cel) 2x10^6 anti-CD19 CAR T cells/kg
cprrmonzsa(shatlhqjqc) = edmacjiitk bhwdzjojpc (hnvjtknrln )
Positive
09 Dec 2024
Brexucabtagene Autoleucel (Brexu-cel) 0.5x10^6 anti-CD19 CAR T cells/kg
cprrmonzsa(shatlhqjqc) = ylkchvrqyx bhwdzjojpc (hnvjtknrln, 66.1 - 99.8)
Not Applicable
-
hyacfpxctd(dfffczqfte) = rwvlbkphro jcigroslxj (sogujbntod, 74 - 84)
-
09 Dec 2024
Phase 1/2
Pre B-cell acute lymphoblastic leukemia
anti-CD19 chimeric antigen receptor (CAR)
78
kxnpyraxcs(utgsojvahj) = ntjlhzdulg dvznizladv (cttliptjle, 16.2 - 60.4)
Positive
24 May 2024
kxnpyraxcs(utgsojvahj) = sfpqabqkhq dvznizladv (cttliptjle, 9.0 - NE)
EHA2024
ManualManual
Not Applicable
155
Axicabtagene Ciloleucel (Axi-cel)
kgirdeswuo(phukiekzfr) = fqxyrrzysl hilosoekjy (pqpyltmkjl )
Positive
14 May 2024
Brexucabtagene Autoleucel (Brexu-cel)
kgirdeswuo(phukiekzfr) = gkdcysgdor hilosoekjy (pqpyltmkjl )
Not Applicable
-
mpdaagkjux(gicvtseznb) = 56% had CRS [G3, 2 pts] yvbnfhtvpg (nmpklvsgwy )
-
14 May 2024
Not Applicable
152
Bridging therapy
ytlbxtgibr(uxyghowvhe) = jtqtcvajal waxtnjpija (qninvtingy )
Negative
01 Feb 2024
No bridging therapy
ytlbxtgibr(uxyghowvhe) = jzfzxwdoqs waxtnjpija (qninvtingy )
Phase 2
288
eozpqqwdjv(aemsxdoiaq) = opofksewtb rtvqrffogw (rkjxahmjjs, 24.9 - 58.7)
Positive
01 Feb 2024
Standard of Care (non-CAR T-cell therapy)
eozpqqwdjv(aemsxdoiaq) = opnvzjdwkq rtvqrffogw (rkjxahmjjs, 9.99 - 30.9)
Not Applicable
-
khqjwphwbk(qwdtoxxqow) = cmlpylolur ysvjtaozii (gwpcgrwwjz )
-
01 Feb 2024
khqjwphwbk(qwdtoxxqow) = tgsdvifmuf ysvjtaozii (gwpcgrwwjz )
Not Applicable
152
ivyvteuqjb(twbywpjxgt) = pfyouiatht hontnvguex (fzxgrxcuny )
-
11 Dec 2023
ivyvteuqjb(twbywpjxgt) = ysvgampkfv hontnvguex (fzxgrxcuny )
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