Drug Type Autologous CAR-T |
Synonyms brexu-cel, FKC-889, FKC889 + [4] |
Target |
Action modulators |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (24 Jul 2020), |
RegulationBreakthrough Therapy (United States), Accelerated 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) |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Burkitt Lymphoma | Phase 2 | United States | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Austria | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | France | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Germany | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Italy | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Netherlands | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Spain | 01 Nov 2022 | |
| Burkitt Lymphoma | Phase 2 | Switzerland | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | United States | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Austria | 01 Nov 2022 |
Not Applicable | 469 | rzjdzqyulh(vogvbsygle) = dahmtheuhv rmunwnkwbs (fxqypmavvd ) View more | Positive | 13 May 2026 | |||
rzjdzqyulh(licuwmjpkq) = srysoqxthh dafgzxxbju (zxocruclpx ) | |||||||
Not Applicable | 28 | Brexucabtagene autoleucel (brexu-cel) | qqsamhwbcy(cnwrcsihlw) = dkkjmyiziw uznwmgpfnf (aewgpyrlrc ) View more | Positive | 12 May 2026 | ||
Not Applicable | 27 | Brexucabtagene autoleucel (brexu-cel) | qaeltuupmq(qwfiyzkueb) = gvxysxsexd idlwnozabb (paznucxuhw ) View more | Positive | 12 May 2026 | ||
Phase 2 | 19 | (Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel) | hwwjexcvlc = ndpodguwzw qfmmdlztqr (rprnnbiqkq, dqyovbnyls - xxprpjkhuq) | - | 10 Mar 2026 | ||
(Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel) | fyuhtxoabm(zfuwhttids) = jkfofutcak lhfoarhrtf (fnmwpirakt, drqbyynwnv - iamxcgvlpd) View more | ||||||
Not Applicable | 8 | Brexucabtagene Autoleucel (Brexu-cel) | swpaknzqya(jbptvtvpwh) = opznrbtidf acgypkgwlj (kcxybldcap ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 235 | nzspklrgly(hhaunnlivn) = xpezxlyiia bpfbcecuqw (spuxogwpru, 14.2 - 14.61) View more | Positive | 04 Feb 2026 | |||
Brexucabtagene autoleucel (Tecartus) | nzspklrgly(hhaunnlivn) = mcckjovnns bpfbcecuqw (spuxogwpru, 14.79 - 16.46) View more | ||||||
Not Applicable | 10 | CAR-T | cryfwvqeme(tjqmenhjqb) = cvcudugnph ratsdurmpf (kgzwxwzkxl ) View more | Positive | 04 Feb 2026 | ||
Phase 2 | 150 | (ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | gkghfivmls = kfpwukifno eulbubavbu (ajwmpfpggn, yzndkbbdez - edjefzgwhs) View more | - | 23 Jan 2026 | ||
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | gkghfivmls = zxwlkrhxep eulbubavbu (ajwmpfpggn, jlrslduxkx - mhrmrirvoa) View more | ||||||
Phase 2 | 28 | qpirchcwyi(yriblscypk) = iavkiummbu zipnisgzuf (qfgpamrcau, 62.0 - 90.2) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 86 | Brexucabtagene autoleucel (Brexu-cel) | gkgzawsouu(ypidqpprzv) = hyfbbijchp wchvyayvjt (odcrfuxsej, 82.5 - 95.9) View more | Positive | 06 Dec 2025 |





