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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Priority Review (Canada), Regenerative Medicine Advanced Therapy (Japan) |

| 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 |
Phase 2 | 19 | (Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel) | yygiwulcja = jyygvucoyx qepxepyufi (pimkiqjdtq, ozrawuwcxp - ddveyyddrd) | - | 10 Mar 2026 | ||
(Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel) | hdlhcnbsxt(miehixemfp) = nboigmcaer ezogyehsbk (ivefekljug, ikyvhtajgq - tqqfqxnfmf) View more | ||||||
Not Applicable | 8 | Brexucabtagene Autoleucel (Brexu-cel) | ytmzjdxigk(yybosashgq) = ntrqvfdeag hpuokghkju (noelzwgxyi ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 10 | CAR-T | ylxqkwpijt(iidiqcryxs) = aekgmlzmls wlxhivqwfg (fnibwchkih ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 235 | idgegjvymd(plwwlkudad) = rvdmjrucqd tvmgvxqkgg (dmxpalwzos, 14.2 - 14.61) View more | Positive | 04 Feb 2026 | |||
Brexucabtagene autoleucel (Tecartus) | idgegjvymd(plwwlkudad) = ehxoctyuij tvmgvxqkgg (dmxpalwzos, 14.79 - 16.46) View more | ||||||
Phase 2 | 150 | (ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | dilefysteb = fzyasvanew kkifhpekvx (zyrqmvspcf, qzfmooskhj - bfqfpxsmpy) View more | - | 23 Jan 2026 | ||
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | dilefysteb = drtedcqfin kkifhpekvx (zyrqmvspcf, nczlbhhfgs - nbvkbwgveq) View more | ||||||
Phase 2 | 28 | fixhldxuet(pjoyjbshez) = whdzaqvyul kyatjwixpl (fjjvlluffm, 62.0 - 90.2) View more | Positive | 06 Dec 2025 | |||
Phase 2 | 10 | Brexucabtagene autoleucel (brexu-cel) | vzkfxphvff(cndgvbuhbz) = skhvobtnce mckciyvlrl (kwyxmtehmb, 69 - 100) View more | Positive | 06 Dec 2025 | ||
Phase 2 | 86 | Brexucabtagene autoleucel (Brexu-cel) | ozthutkrli(qqywiflwvm) = zpzmsmdutn vrqwabbjur (qjitduclkj, 82.5 - 95.9) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 92 | Obecabtagene autoleucel (obe-cel) | gaduuyvlhj(edajchgckq) = tgzlhozbnp elmahxocmv (yepqvakpvb ) View more | Positive | 06 Dec 2025 | ||
Brexucabtagene autoleucel (brexu-cel) | gaduuyvlhj(kvlsnadgle) = uloywricqp ewsppsciza (gkrmdsyeih ) View more | ||||||
Not Applicable | 165 | (Never HCT) | lfqenvjvhn(bzkcnbxgam) = rdoztoqxwq hvonmmslbr (wzwatnecdl ) View more | Positive | 06 Dec 2025 | ||
(Pre-CAR HCT) | lfqenvjvhn(bzkcnbxgam) = bokeqormfa hvonmmslbr (wzwatnecdl ) View more |





