OnCo
drugsProductNot mapped hereapproved

Brexucabtagene autoleucel

Brexucabtagene autoleucel is the CAR-T therapy for mantle cell lymphoma and adult acute lymphoblastic leukaemia, giving long remissions after BTK inhibitors fail.

ZUMA-2 (NEJM 2020): 93% response, 67% CR in BTKi-exposed MCL, with ~30-month median PFS in updates. ZUMA-3: 71% CR/CRi in adult R/R B-ALL (approval 2021). Cytokine release and neurotoxicity rates are high (grade ≥3 neuro ~30%).

Schematic of the modality · Autologous CD19 CAR-T (CD28 costimulatory domain) · not a molecule; see the CAR-T cell therapy page
How it works, step by step · animated schematic, not to scale
CAR-T cell therapy
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.
Brand / code
Tecartus
Medicare
Part B (clinician-administered)NCD 110.24

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.

Commercial insurance
covered with prior authorisation

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.

Cancer Drugs FundNICE TA677 · 2021SMC: accepted
Appraised for
Relapsed or refractory mantle cell lymphoma after a BTK inhibitor
Notes
Adult B-ALL indication appraised separately (2023).
Cancer Drugs Fund
Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
NHS England
Routinely funded for the appraised indication (or via managed access)

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.

Regulatory

3top

Approvals

RegionYearIndication
US2020Relapsed/refractory mantle cell lymphoma
US2021Relapsed/refractory B-ALL in adults
EU2020MCL after ≥2 lines including a BTK inhibitor

Trials

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
13 studies6 recruiting13 Phase 2
Search “Brexucabtagene autoleucel” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Brexucabtagene autoleucel
intervention: Brexucabtagene autoleucel
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Key papers

1top

Latest papers

top
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

8top

Pages like this

not linked directly; found by shared links