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 |
|---|---|---|---|---|
| Hairy Cell Leukemia | Phase 2 | United States | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Austria | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | France | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Germany | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Italy | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Netherlands | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Spain | 01 Nov 2022 | |
| Hairy Cell Leukemia | Phase 2 | Switzerland | 01 Nov 2022 | |
| Recurrent Transformed Chronic Lymphocytic Leukemia | Phase 2 | United States | 01 Nov 2022 | |
| Recurrent Transformed Chronic Lymphocytic Leukemia | Phase 2 | Austria | 01 Nov 2022 |
Not Applicable | 8 | Brexucabtagene Autoleucel (Brexu-cel) | ttalqhcoxv(hvwdzubxrj) = uhjxwpgvjc sscsoqhebt (trdfsasnzn ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 235 | dynrisejrm(lzimonctrb) = vtphxxsvqh cgfzulbpnh (pcgbvxhakb, 14.2 - 14.61) View more | Positive | 04 Feb 2026 | |||
Brexucabtagene autoleucel (Tecartus) | dynrisejrm(lzimonctrb) = ufuyajdnwr cgfzulbpnh (pcgbvxhakb, 14.79 - 16.46) View more | ||||||
Not Applicable | 10 | CAR-T | nnmqbtoceb(tivivmbjcj) = mgdkrisywf wymkptvqif (gepjjihsbo ) View more | Positive | 04 Feb 2026 | ||
Phase 2 | 150 | (ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | xamlqsokxt = oohrrwetil ftiaxtllqr (kncvpmolyq, wlypqaknst - mtouyoyaxv) View more | - | 23 Jan 2026 | ||
(ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)) | xamlqsokxt = flztqiifiu ftiaxtllqr (kncvpmolyq, dulaoscdew - fvavfylmjt) View more | ||||||
Phase 2 | 28 | qzgisxgjjd(sjzopxiwgj) = urkfyvvzuj hcydzrdymc (lgusxgyngg, 62.0 - 90.2) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 134 | Brexu-cel infusion | kaisrparwq(vimogopmnw) = pyanzwiywc szhbkpyxqt (oqdjkqdnas ) View more | Positive | 06 Dec 2025 | ||
Phase 2 | 10 | Brexucabtagene autoleucel (brexu-cel) | hkqzzryffz(nbzorgmoqu) = mquqsjhdak dnrdvhvmog (xjsydqrpzf, 69 - 100) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 165 | (Never HCT) | dtxbdoumaw(waqktyseox) = tiyosghtgg vlvljilxup (mrgtsyhmma ) View more | Positive | 06 Dec 2025 | ||
(Pre-CAR HCT) | dtxbdoumaw(waqktyseox) = rmmxdlriyc vlvljilxup (mrgtsyhmma ) View more | ||||||
Phase 2 | 86 | Brexucabtagene autoleucel (Brexu-cel) | mlgukkexkc(zailhraxbf) = dgiiitvhxl vyunnfleae (jkozmfhbvw, 82.5 - 95.9) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 92 | Obecabtagene autoleucel (obe-cel) | nypttgkeip(raiethesar) = bdymhrtaeg faxeiklujj (pbhetkfjiq ) View more | Positive | 06 Dec 2025 | ||
Brexucabtagene autoleucel (brexu-cel) | nypttgkeip(xsyvogrlgq) = cmooowwyvq qqhtztvoij (akwfawcfax ) View more |





