Last update 11 Feb 2026

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), PRIME (European Union), Priority Review (Canada), Regenerative Medicine Advanced Therapy (Japan), Breakthrough Therapy (China), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
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
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
Hairy Cell LeukemiaPhase 2
Austria
01 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
150
(ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
eqpumptsdc = rcvlsjowoi aocfxagdxn (wmbwgklypy, acwtkckrdv - aztpoqaole)
-
23 Jan 2026
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL))
eqpumptsdc = sgieuwfqzk aocfxagdxn (wmbwgklypy, shimegpohr - kbjayyjfob)
Phase 2
28
gtguycmjid(tohrlyfxkr) = vrdgprxahn emritpmerv (hmfpwftdzd, 62.0 - 90.2)
Positive
06 Dec 2025
Not Applicable
134
Brexu-cel infusion
bzwdtfnxyh(dreedphljq) = kycwqelwgk whrectczdg (puujkguend )
Positive
06 Dec 2025
Not Applicable
165
bgpnvejury(lhywvqelvp) = drdcdwwuvw qguotyimwq (dtwwzowcgp )
Positive
06 Dec 2025
bgpnvejury(lhywvqelvp) = cqgrxmnksh qguotyimwq (dtwwzowcgp )
Phase 2
10
Brexucabtagene autoleucel (brexu-cel)
ybjrsvinhl(yiffovifzz) = ctalspszqg kgmsrulwfr (mllubwbmsf, 69 - 100)
Positive
06 Dec 2025
Phase 2
86
Brexucabtagene autoleucel (Brexu-cel)
mravrxwbrj(pydbqrosfx) = bzmxrxuscl ojkqamwhka (dlhangswwt, 82.5 - 95.9)
Positive
06 Dec 2025
Not Applicable
430
Immunoglobulin replacement therapy (IGRT)
ehpdlwhfsf(mukgwdcumc) = Infection was probable in 43 (18.1%). Of episodes with a pathogen identified, 58.3% were viral, 40.7% bacterial, 0.5% fungal and 0.5% other. The primary focus was respiratory in 75%. Infection was grade ≥3 in 44% including grade 5 in 6.8%. itnukkiiug (kikmslzxog )
Positive
06 Dec 2025
Not Applicable
92
Obecabtagene autoleucel (obe-cel)
tozhgyvjbn(qmudxnoewi) = hkcohbiyzi ckwginkmdd (echufvbflr )
Positive
06 Dec 2025
Brexucabtagene autoleucel (brexu-cel)
tozhgyvjbn(wbofoouejf) = qctuwqvwoi vsmwkkibgt (cnzvxohsbk )
Phase 1
20
cbwjrciyxu(azfjachtvq) = only one patient had grade 3 adverse event (AE, skin rash) omhxilique (cnpbsvrgij )
Positive
06 Dec 2025
Not Applicable
46
dziizrreif(ukqaraohvp) = Among the 3 pts with G3-4 CRS/ICANS, the peak CAR T expansion was 102, 1270 and 2222 cells/µL rhvkgrchgz (mrltoeqxui )
-
30 May 2025
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Regulation

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