Last update 01 Nov 2024

Brexucabtagene Autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
brexu-cel, FKC-889, FKC889
+ [4]
Target
Mechanism
CD19 modulators(B-lymphocyte antigen CD19 modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Priority Review (CA), Priority Review (US), Accelerated Approval (US), PRIME (EU), Orphan Drug (EU)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pre B-cell acute lymphoblastic leukemia
AU
30 Sep 2022
Mantle cell lymphoma recurrent
EU
14 Dec 2020
Mantle cell lymphoma recurrent
IS
14 Dec 2020
Mantle cell lymphoma recurrent
LI
14 Dec 2020
Mantle cell lymphoma recurrent
NO
14 Dec 2020
Mantle cell lymphoma refractory
EU
14 Dec 2020
Mantle cell lymphoma refractory
IS
14 Dec 2020
Mantle cell lymphoma refractory
LI
14 Dec 2020
Mantle cell lymphoma refractory
NO
14 Dec 2020
Acute Lymphoblastic Leukemia
US
24 Jul 2020
Mantle-Cell Lymphoma
US
24 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 2
US
26 Dec 2023
Burkitt LymphomaPhase 2
US
01 Nov 2022
Burkitt LymphomaPhase 2
AT
01 Nov 2022
Burkitt LymphomaPhase 2
FR
01 Nov 2022
Burkitt LymphomaPhase 2
DE
01 Nov 2022
Burkitt LymphomaPhase 2
IT
01 Nov 2022
Burkitt LymphomaPhase 2
NL
01 Nov 2022
Burkitt LymphomaPhase 2
ES
01 Nov 2022
Burkitt LymphomaPhase 2
CH
01 Nov 2022
Hairy Cell LeukemiaPhase 2
US
01 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Pre B-cell acute lymphoblastic leukemia
anti-CD19 chimeric antigen receptor (CAR)
78
mrwiafebyo(dvlbaymxhm) = faxidsogrc xgmtaztvoo (mbdqpljspt, 16.2 - 60.4)
Positive
24 May 2024
(Age <26 years)
mrwiafebyo(dvlbaymxhm) = qvtpuoazva xgmtaztvoo (mbdqpljspt, 9.0 - NE)
EHA2024
ManualManual
Not Applicable
155
axi-cel or brexu-cel
(early mgmt period [EMP])
lljvjtqmta(miaaegferh) = dcphsernjw iptyfmtibf (azhusbllfv )
Positive
14 May 2024
axi-cel or brexu-cel
(late mgmt period [LMP])
lljvjtqmta(miaaegferh) = lprbebyzzr iptyfmtibf (azhusbllfv )
Not Applicable
-
mzmbhbgxtp(fwjyqorbck) = 56% had CRS [G3, 2 pts] zboyrspxjb (bubjbfqwqk )
-
14 May 2024
Phase 2
288
etybxgyudo(zhocucqyii) = ythnbmpyqx esykqolyie (eszsfytpzp, 24.9 - 58.7)
Positive
01 Feb 2024
Standard of Care (non-CAR T-cell therapy)
etybxgyudo(zhocucqyii) = firpigggrb esykqolyie (eszsfytpzp, 9.99 - 30.9)
Not Applicable
152
Brexucabtagene autoleucel
(Bridging therapy)
mfcabyxrbq(ihwqztzamg) = trfpkjucet lopvuzwzut (zuwywmrcsk )
Negative
01 Feb 2024
Brexucabtagene autoleucel
(No bridging therapy)
mfcabyxrbq(ihwqztzamg) = awkymxuwrj lopvuzwzut (zuwywmrcsk )
Not Applicable
152
fdvtunerxd(ehxihgwoxo) = wzloivojaq uphejbnuax (kpqqyfxqxs )
-
11 Dec 2023
fdvtunerxd(ehxihgwoxo) = uoahqkuacu uphejbnuax (kpqqyfxqxs )
Not Applicable
197
pwwsgkgudl(cxpkibpcwr) = ylbbwimase qkskykrnjy (knmuzyphcs )
-
11 Dec 2023
Phase 2
152
chhmynrofu(kzmdugmxtn) = 82% developed CRS, the majority was grade 1-2, with 9% of the overall cohort experiencing grade 3-4 CRS qolkegovnv (mlknvhhwea )
-
11 Dec 2023
Not Applicable
111
pkwijbthzk(omfwiibzfn) = fqqlkcwjjc bwtoqbibkv (fvnivtrxvw )
-
11 Dec 2023
Not Applicable
68
bmmncafczi(lylxdqonjj): cause specific hazard ratio = 7.7 (95% CI, 1.9 - 31.6), P-Value = 0.005
-
10 Dec 2023
(Allogeneic Stem Cell Transplantation)
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