{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T01:33:48Z","timestamp":1790732028812,"version":"4.1.0"},"reference-count":30,"publisher":"American Society of Hematology","issue":"1","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,7,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>In October 2021, brexucabtagene autoleucel became the first anti-CD19 chimeric antigen receptor T-cell product to receive approval from the Food and Drug Administration to treat adults with relapsed and refractory B-cell acute lymphoblastic leukemia. The approval is based on results from the Zuma-3 trial and significantly widens treatment options for this patient population. In this article, we review outcomes from this study and its implications.<\/jats:p>","DOI":"10.1182\/blood.2021014892","type":"journal-article","created":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T17:53:22Z","timestamp":1651686802000},"page":"11-15","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":52,"title":["Approval of brexucabtagene autoleucel for adults with relapsed and refractory acute lymphocytic leukemia"],"prefix":"10.1182","volume":"140","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3688-9836","authenticated-orcid":false,"given":"Noelle V.","family":"Frey","sequence":"first","affiliation":[{"name":"Cell Therapy and Transplant, Division of Hematology Oncology, Abramson Cancer Center, Hospital of the University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","reference":[{"issue":"5","key":"2022070715214583700_B1","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1056\/NEJMoa1709866","article-title":"Tisagenlecleucel in children and young adults with B-Cell lymphoblastic leukemia","volume":"378","author":"Maude","year":"2018","journal-title":"N Engl J Med."},{"issue":"16","key":"2022070715214583700_B2","doi-asserted-by":"crossref","first-page":"1507","DOI":"10.1056\/NEJMoa1407222","article-title":"Chimeric antigen receptor T cells for sustained remissions in leukemia","volume":"371","author":"Maude","year":"2014","journal-title":"N Engl J Med."},{"issue":"26","key":"2022070715214583700_B3","doi-asserted-by":"crossref","first-page":"2531","DOI":"10.1056\/NEJMoa1707447","article-title":"Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma","volume":"377","author":"Neelapu","year":"2017","journal-title":"N Engl J Med."},{"issue":"1","key":"2022070715214583700_B4","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1056\/NEJMoa1804980","article-title":"Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma","volume":"380","author":"Schuster","year":"2019","journal-title":"N Engl J Med."},{"issue":"14","key":"2022070715214583700_B5","doi-asserted-by":"crossref","first-page":"1331","DOI":"10.1056\/NEJMoa1914347","article-title":"KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma","volume":"382","author":"Wang","year":"2020","journal-title":"N Engl J Med."},{"issue":"10254","key":"2022070715214583700_B6","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1016\/S0140-6736(20)31366-0","article-title":"Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study","volume":"396","author":"Abramson","year":"2020","journal-title":"Lancet."},{"key":"2022070715214583700_B7","article-title":"Clinical outcomes for the phase 2, single-arm, multicenter trial of JCAR015 in adult B-ALL (ROCKET Study) [abstract]","author":"DeAngelo","year":"2017","journal-title":"J Immunother Cancer."},{"issue":"5","key":"2022070715214583700_B8","doi-asserted-by":"crossref","first-page":"415","DOI":"10.1200\/JCO.19.01892","article-title":"Optimizing chimeric antigen receptor T-cell therapy for adults with acute lymphoblastic leukemia","volume":"38","author":"Frey","year":"2020","journal-title":"J Clin Oncol."},{"issue":"15","key":"2022070715214583700_B9","doi-asserted-by":"crossref","first-page":"1652","DOI":"10.1182\/blood-2018-11-883710","article-title":"Factors associated with durable EFS in adult B-cell ALL patients achieving MRD-negative CR after CD19 CAR T-cell therapy","volume":"133","author":"Hay","year":"2019","journal-title":"Blood."},{"issue":"5","key":"2022070715214583700_B10","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1056\/NEJMoa1709919","article-title":"Long-term follow-up of CD19 CAR therapy in acute lymphoblastic leukemia","volume":"378","author":"Park","year":"2018","journal-title":"N Engl J Med."},{"issue":"16","key":"2022070715214583700_B11","doi-asserted-by":"crossref","first-page":"1509","DOI":"10.1056\/NEJMoa1215134","article-title":"Chimeric antigen receptor-modified T cells for acute lymphoid leukemia","volume":"368","author":"Grupp","year":"2013","journal-title":"N Engl J Med."},{"issue":"10","key":"2022070715214583700_B12","doi-asserted-by":"crossref","first-page":"e711","DOI":"10.1016\/S2352-3026(21)00238-6","article-title":"CD19-targeted chimeric antigen receptor T-cell therapy for CNS relapsed or refractory acute lymphocytic leukaemia: a post-hoc analysis of pooled data from five clinical trials","volume":"8","author":"Leahy","year":"2021","journal-title":"Lancet Haematol."},{"issue":"6","key":"2022070715214583700_B13","doi-asserted-by":"crossref","first-page":"2123","DOI":"10.1172\/JCI85309","article-title":"CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients","volume":"126","author":"Turtle","year":"2016","journal-title":"J Clin Invest."},{"issue":"30","key":"2022070715214583700_B14","doi-asserted-by":"crossref","first-page":"3352","DOI":"10.1200\/JCO.21.00917","article-title":"Durable responses and low toxicity after fast off-rate CD19 chimeric antigen receptor-T therapy in adults with relapsed or refractory B-cell acute lymphoblastic leukemia","volume":"39","author":"Roddie","year":"2021","journal-title":"J Clin Oncol."},{"issue":"1","key":"2022070715214583700_B15","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1182\/blood.2020009098","article-title":"KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed\/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results","volume":"138","author":"Shah","year":"2021","journal-title":"Blood."},{"issue":"10299","key":"2022070715214583700_B16","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1016\/S0140-6736(21)01222-8","article-title":"KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study","volume":"398","author":"Shah","year":"2021","journal-title":"Lancet."},{"issue":"4","key":"2022070715214583700_B17","doi-asserted-by":"crossref","first-page":"e123","DOI":"10.1016\/j.bbmt.2018.12.756","article-title":"Cytokine release syndrome with chimeric antigen receptor T cell therapy","volume":"25","author":"Frey","year":"2019","journal-title":"Biol Blood Marrow Transplant."},{"issue":"25","key":"2022070715214583700_B18","doi-asserted-by":"crossref","first-page":"3322","DOI":"10.1182\/blood-2017-02-769208","article-title":"Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults","volume":"129","author":"Gardner","year":"2017","journal-title":"Blood."},{"issue":"27","key":"2022070715214583700_B19","doi-asserted-by":"crossref","first-page":"3044","DOI":"10.1200\/JCO.20.03458","article-title":"Humanized CD19-targeted chimeric antigen receptor (CAR) T cells in CAR-naive and CAR-exposed children and young adults with relapsed or refractory acute lymphoblastic leukemia","volume":"39","author":"Myers","year":"2021","journal-title":"J Clin Oncol."},{"issue":"2","key":"2022070715214583700_B20","doi-asserted-by":"crossref","first-page":"636","DOI":"10.1016\/j.ymthe.2020.09.027","article-title":"CART19-BE-01: a multicenter trial of ARI-0001 cell therapy in patients with CD19+ relapsed\/refractory malignancies","volume":"29","author":"Ort\u00edz-Maldonado","year":"2021","journal-title":"Mol Ther."},{"issue":"15","key":"2022070715214583700_B21","doi-asserted-by":"crossref","first-page":"1650","DOI":"10.1200\/JCO.20.02262","article-title":"Long-term follow-up of CD19-CAR T-cell therapy in children and young adults with B-ALL","volume":"39","author":"Shah","year":"2021","journal-title":"J Clin Oncol."},{"issue":"9","key":"2022070715214583700_B22","doi-asserted-by":"crossref","first-page":"836","DOI":"10.1056\/NEJMoa1609783","article-title":"Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia","volume":"376","author":"Kantarjian","year":"2017","journal-title":"N Engl J Med."},{"issue":"8","key":"2022070715214583700_B23","doi-asserted-by":"crossref","first-page":"740","DOI":"10.1056\/NEJMoa1509277","article-title":"Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia","volume":"375","author":"Kantarjian","year":"2016","journal-title":"N Engl J Med."},{"issue":"14","key":"2022070715214583700_B24","doi-asserted-by":"crossref","first-page":"2474","DOI":"10.1002\/cncr.32116","article-title":"Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study","volume":"125","author":"Kantarjian","year":"2019","journal-title":"Cancer."},{"issue":"4","key":"2022070715214583700_B25","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1002\/cncr.33298","article-title":"Long-term survival of patients with relapsed\/refractory acute lymphoblastic leukemia treated with blinatumomab","volume":"127","author":"Topp","year":"2021","journal-title":"Cancer."},{"issue":"10","key":"2022070715214583700_B26","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.1038\/s41591-020-1081-3","article-title":"Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial","volume":"26","author":"Shah","year":"2020","journal-title":"Nat Med."},{"key":"2022070715214583700_B27","article-title":"Minimal residual disease negative complete remissions following anti-CD22 chimeric antigen receptor (CAR) in children and young adults with relapsed\/refractory acute lymphoblastic lymphoma (ALL) [abstract]","author":"Shah","year":"2016","journal-title":"Blood."},{"issue":"5","key":"2022070715214583700_B28","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1038\/s41591-021-01326-5","article-title":"Antigen-independent activation enhances the efficacy of 4-1BB-costimulated CD22 CAR T cells","volume":"27","author":"Singh","year":"2021","journal-title":"Nat Med."},{"issue":"24","key":"2022070715214583700_B29","doi-asserted-by":"crossref","first-page":"2149","DOI":"10.1182\/blood.2019001463","article-title":"Preemptive mitigation of CD19 CAR T-cell cytokine release syndrome without attenuation of antileukemic efficacy","volume":"134","author":"Gardner","year":"2019","journal-title":"Blood."},{"issue":"10266","key":"2022070715214583700_B30","doi-asserted-by":"crossref","first-page":"1885","DOI":"10.1016\/S0140-6736(20)32334-5","article-title":"Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies","volume":"396","author":"Benjamin","year":"2020","journal-title":"Lancet."}],"container-title":["Blood"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/140\/1\/11\/1905406\/bloodbld2021014892c.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/ashpublications.org\/blood\/article-pdf\/140\/1\/11\/1905406\/bloodbld2021014892c.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T15:22:20Z","timestamp":1657207340000},"score":1,"resource":{"primary":{"URL":"https:\/\/ashpublications.org\/blood\/article\/140\/1\/11\/485154\/Approval-of-brexucabtagene-autoleucel-for-adults"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,7]]},"references-count":30,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,7,7]]}},"URL":"https:\/\/doi.org\/10.1182\/blood.2021014892","relation":{},"ISSN":["0006-4971","1528-0020"],"issn-type":[{"value":"0006-4971","type":"print"},{"value":"1528-0020","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,7]]}}}