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Brexucabtagene autoleucel is the CAR-T therapy for mantle cell lymphoma and adult acute lymphoblastic leukaemia, giving long remissions after BTK inhibitors fail.
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.
Anti-CD19 CAR T cells manufactured with T-cell enrichment to remove circulating tumour cells; same construct as axicabtagene. Connects to CD19.
1.Brexucabtagene autoleucel slips into a pocket on CD19.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Autologous CAR-T covered nationally under NCD 110.24 for FDA-labelled indications at facilities enrolled in the FDA REMS. Inpatient administration is paid under Part A (MS-DRG 018); outpatient administration is a Part B drug. The product itself is bundled into the facility payment. HCPCS Q2053.
Covered with prior authorisation and usually a single-case agreement with a certified treatment centre; many plans restrict to centres of excellence and require documentation of prior lines of therapy.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · CMS NCD 110.24: Chimeric antigen receptor (CAR) T-cell therapy · Medicare.gov: Inpatient hospital care (Part A). Not medical or financial advice; verify with your plan.
Sources: NICE TA677 · NHS England Cancer Drugs Fund list · SMC advice: brexucabtagene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Confirmed: the accelerated approval of 2020 converted to traditional approval 5.7 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Relapsed/refractory mantle cell lymphoma |
| US | 2021 | Relapsed/refractory B-ALL in adults |
| EU | 2020 | MCL after ≥2 lines including a BTK inhibitor |
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Query for this drug: (TITLE:"Brexucabtagene autoleucel" OR ABSTRACT:"Brexucabtagene autoleucel" OR TITLE:"Tecartus" OR ABSTRACT:"Tecartus") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Brexucabtagene autoleucel, not a curated reading list.
Shares CD28, CD19 expression (CD19-positive), Cytokine release syndrome and ICANS: grading and management, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting.
Shares ZUMA-2, ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors, CD19, Mantle cell lymphoma.
Shares Autologous CAR-T manufacturing, batch by batch, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.
Shares CD28, CD19 expression (CD19-positive), Cytokine release syndrome and ICANS: grading and management, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting.
Shares CD19 expression (CD19-positive), Cytokine release syndrome and ICANS: grading and management, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, Autologous CAR-T manufacturing, batch by batch.
Shares ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors, ICANS (neurotoxicity), Gilead Sciences (incl. Kite), Cytokine release syndrome (CRS).
Shares The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ICANS (neurotoxicity), Mantle cell lymphoma, CAR-T cell therapy.
Shares The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.