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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.
Autologous CD19 CAR-T (4-1BB) manufactured as separate CD4 and CD8 components and infused at a fixed ratio. Connects to CD19.
1.Leukapheresis; CD4 and CD8 T cells transduced and expanded separately
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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.
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 TA1048. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2019-01-03 | Celgene to Bristol Myers Squibb Revlimid, Pomalyst, bb2121 (Abecma), liso-cel (Breyanzi) and the Celgene pipeline | Acquisition | not disclosed | $74bn (plus a contingent value right) | source |
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First CAR-T in CLL (TRANSCEND CLL 004), accelerated
Adult patients with relapsed/ refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.5 years later, when the FDA's table was read.
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy
Confirmed: the accelerated approval of 2024 converted to traditional approval 1.8 years after it was granted. source
| 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.
Read for the class this product belongs to (car-t cell therapy) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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TRANSFORM confirmed ZUMA-7's conclusion with a different CD19 CAR-T and a more permissive design that allowed bridging chemotherapy, making the results closer to real-world practice. Liso-cel's low toxicity makes it attractive for older or frailer patients and for outpatient delivery. Together the two trials made CAR-T the standard second-line therapy for early-relapsing aggressive lymphoma.
The evidence that made lisocabtagene maraleucel the CD19 CAR-T product most often chosen for older or frailer patients, because its severe cytokine release syndrome rate is a fraction of the other two products'.
Query 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.
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 TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study, TRANSCEND NHL 001.
Shares CD28, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, CD19 expression (CD19-positive).
Shares Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, CD19 expression (CD19-positive), Cytokine release syndrome and ICANS: grading and management.
Shares The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ICANS (neurotoxicity), Primary mediastinal (thymic) large B-cell lymphoma, Mantle cell lymphoma.
Shares TRANSCEND NHL 001, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ICANS (neurotoxicity), Cytokine release syndrome (CRS).
Shares TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, TRANSCEND NHL 001, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting.
Shares TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, ICANS (neurotoxicity), Cytokine release syndrome (CRS).