Lisocabtagene maraleucel
Lisocabtagene maraleucel is the only CAR-T approved for chronic lymphocytic leukaemia, for patients whose disease has outrun both BTK and BCL-2 inhibitors.
TRANSCEND CLL 004: in CLL/SLL after BTK and venetoclax failure, CR/CRi 18-20%, ORR 47%, uMRD in blood 64%, durable in complete responders; accelerated approval March 2024. Also approved in LBCL (second line, TRANSFORM), follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma (2025). Defined 1:1 CD4:CD8 composition; 4-1BB costimulation. Lower CRS/ICANS than CD28-based products.
1.Leukapheresis; CD4 and CD8 T cells transduced and expanded separately
- Route
- Single IV infusion (two components)
- Schedule
- 90-110 × 10^6 CAR+ T cells (CLL)
- Monitoring
- CRS/ICANS (boxed warning), prolonged cytopenias, hypogammaglobulinaemia, secondary T-cell malignancy warning
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- 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 Q2054. Often given outpatient, which shifts the product to Part B with 20% coinsurance.
- 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.
- Notes
- EU-licensed 2022; UK licence and NICE appraisal (second-line and third-line DLBCL) not yet researched.
Sources: NICE search: lisocabtagene maraleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 14 Mar 2024ApprovalUS
First CAR-T in CLL (TRANSCEND CLL 004), accelerated
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Relapsed/refractory LBCL after ≥2 lines |
| US | 2022 | Second-line LBCL (TRANSFORM) |
| US | 2024 | Relapsed/refractory CLL/SLL after BTK inhibitor and BCL-2 inhibitor (accelerated) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 83% | 9% |
| Neurotoxicity | 46% | 20% |
| Prolonged cytopenias | — | 54% |
TRANSCEND CLL 004. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Lisocabtagene maraleucel" OR ABSTRACT:"Lisocabtagene maraleucel" OR TITLE:"Breyanzi" OR ABSTRACT:"Breyanzi" OR TITLE:"liso-cel" OR ABSTRACT:"liso-cel") 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 Lisocabtagene maraleucel, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductBrexucabtagene autoleucel
Shares ICANS (neurotoxicity), Mantle cell lymphoma, Cytokine release syndrome (CRS), CD19.
- Key paperJULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19, Diffuse large B-cell lymphoma.
- Key paperZUMA-1: axicabtagene ciloleucel for refractory large B-cell lymphoma, the first CAR-T approved for lymphoma
Shares ICANS (neurotoxicity), Follicular lymphoma, Cytokine release syndrome (CRS), CD19.
- ProductIdecabtagene vicleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), Bristol Myers Squibb, CAR-T cell therapy.
- Key paperZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors
Shares ICANS (neurotoxicity), Mantle cell lymphoma, Cytokine release syndrome (CRS), CD19.
- ProductTisagenlecleucel
Shares ICANS (neurotoxicity), Follicular lymphoma, Cytokine release syndrome (CRS), CD19.
- TrialTRANSFORM
Shares TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, CD19, Diffuse large B-cell lymphoma, CAR-T cell therapy.
- Key paperZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early
Shares TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.