{"entity":{"id":"brexucabtagene-autoleucel","kind":"drug","name":"Brexucabtagene autoleucel","aka":[],"tldr":"Brexucabtagene autoleucel is the CAR-T therapy for mantle cell lymphoma and adult acute lymphoblastic leukaemia, giving long remissions after BTK inhibitors fail.","summary":"Brexucabtagene autoleucel is an autologous CD19 CAR-T with a CD28 costimulatory domain, the same construct as axicabtagene, manufactured with a T-cell enrichment step that removes circulating tumour cells from the leukapheresis product. It is used for relapsed or refractory mantle cell lymphoma after BTK inhibitor failure and for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. ZUMA-2 (NEJM 2020) reported a 93% response rate and 67% complete remissions in BTKi-exposed MCL, with a median progression-free survival of about 30 months in updates. ZUMA-3 showed 71% CR or CRi in adult B-ALL, leading to the 2021 approval. Cytokine release syndrome and neurotoxicity are frequent, with grade 3 or higher neurological events in roughly 30%. In short, one infusion can produce long remissions in two diseases that were hard to control after relapse.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Brexucabtagene_autoleucel","links":[{"label":"ZUMA-2 (NEJM 2020)","url":"https://doi.org/10.1056/NEJMoa1914347"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Tecartus"}],"tags":["gap-fill"],"related":[],"cancers":["mantle-cell-lymphoma","all-leukemia"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":["gilead"],"institutions":[],"pathways":[],"terms":["crs","icans"],"trials":["nct06253663"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tecartus","modality":"Autologous CD19 CAR-T (CD28 costimulatory domain)","mechanism":"Anti-CD19 CAR T cells manufactured with T-cell enrichment to remove circulating tumour cells; same construct as axicabtagene.","approvals":[{"region":"US","year":2020,"indication":"Relapsed/refractory mantle cell lymphoma"},{"region":"US","year":2021,"indication":"Relapsed/refractory B-ALL in adults"},{"region":"EU","year":2020,"indication":"MCL after ≥2 lines including a BTK inhibitor"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2020-07-24","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)."},{"date":"2026-04-01","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2020 converted to traditional approval 5.7 years after it was granted.","indication":"Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)."}]},"route":"/drugs/brexucabtagene-autoleucel/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"}],"technology":[{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"},{"id":"cd28","kind":"target","name":"CD28","route":"/targets/cd28/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"},{"id":"lymphoma-tx-car-t-pathway","kind":"term","name":"The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting","route":"/terms/lymphoma-tx-car-t-pathway/"},{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"trial":[{"id":"nct06253663","kind":"trial","name":"Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic L","route":"/trials/nct06253663/"},{"id":"zuma-2","kind":"trial","name":"ZUMA-2","route":"/trials/zuma-2/"}],"paper":[{"id":"paper-zuma-2-brexu-cel-mantle-cell-nejm-2020","kind":"paper","name":"ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors","route":"/key-papers/paper-zuma-2-brexu-cel-mantle-cell-nejm-2020/"}],"biomarker":[{"id":"cd19-expression","kind":"biomarker","name":"CD19 expression (CD19-positive)","route":"/biomarkers/cd19-expression/"}]}}