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A CD19 CAR-T that cures about 40% of patients with large B-cell lymphoma who had failed everything, and beat transplant in second line.
Axicabtagene ciloleucel (axi-cel) is an autologous CAR-T: a patient's T cells are engineered with a retroviral vector to express a CD19-binding scFv with a CD28 costimulatory domain and reinfused after cyclophosphamide and fludarabine lymphodepletion. It was approved in 2017 for large B-cell lymphoma after two or more lines (ZUMA-1; 5-year OS about 43%), in 2022 as second-line therapy for early relapse (ZUMA-7, OS benefit), and for follicular lymphoma. Kite/Gilead manufactures it. CD28 costimulation gives fast expansion and more neurotoxicity than 4-1BB products; cytokine release syndrome, prolonged cytopenias and infections are the other main risks. How to choose between CAR-T and CD20xCD3 bispecifics, and how to widen access, remain open. For a newcomer: a one-time living drug that cures a meaningful share of lymphomas with no standard treatment left to try.
CD19 scFv, CD28 costimulation, retroviral. Connects to CD19.
1.Patient's T cells are collected by leukapheresis
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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 Q2041.
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.
National Cancer Institute, Cancer Currents, October 2017 (reporting Kite/Gilead's announced price) (2017). Net prices after rebates are usually lower.
Medicare patients usually face the Part A inpatient deductible rather than 20% of the product price; the hospital stay, apheresis and bridging therapy drive the bill.
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 TA559 · NHS England Cancer Drugs Fund list · SMC advice: axicabtagene ciloleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Relapsed/refractory large B-cell lymphoma after ≥2 lines (ZUMA-1): second CAR-T ever approved source
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Relapsed/refractory follicular lymphoma (ZUMA-5) The confirmatory requirement was still open 5.5 years later, when the FDA's table was read. source
Second-line LBCL refractory or relapsed within 12 months (ZUMA-7) source
Class boxed warning for T-cell malignancies source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Relapsed/refractory large B-cell lymphoma ≥2 lines |
| US | 2022 | Second-line LBCL refractory or relapsed within 12 months |
| Adverse event |
|---|
| Cytokine release syndrome ZUMA-7: ~92% any grade, 6% grade ≥3 |
| Neurologic toxicity ZUMA-7: ~60% any grade, 21% grade ≥3 |
| Prolonged cytopenias |
| Infections |
| Hypogammaglobulinaemia |
Events listed without rates were not read from a primary source; see the label. 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | $373,000 per infusion (list price at launch 2017; higher today) | kitekonnect.com |
| United Kingdom | NICE: recommended for relapsed/refractory DLBCL after ≥2 therapies (TA872) and second-line early relapse (TA895) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Axicabtagene ciloleucel as an option in relapsed follicular and marginal zone lymphoma. Compared with tisagenlecleucel in ELARA, the response rates are higher and the neurological toxicity substantially greater, which is the trade-off a patient and centre weigh.
ZUMA-7 rewrote second-line treatment for aggressive lymphoma: patients whose disease returns within a year of R-CHOP should be offered CAR-T rather than salvage chemotherapy and transplant. It is also one of the few cell-therapy trials to show an overall survival benefit despite crossover. Patients relapsing later than 12 months were not studied and transplant remains standard for them if chemosensitive.
ZUMA-1 showed that CAR-T can cure a meaningful fraction of adults whose aggressive lymphoma no longer responds to chemotherapy, a group with a historical median survival of about six months (SCHOLAR-1). Axi-cel became the first CAR-T approved for lymphoma and later the first to beat standard second-line therapy in ZUMA-7. The comparatively high neurotoxicity of CD28-costimulated products was also first characterised here.
Query for this drug: (TITLE:"Axicabtagene ciloleucel" OR ABSTRACT:"Axicabtagene ciloleucel" OR TITLE:"Yescarta" OR ABSTRACT:"Yescarta" OR TITLE:"axi-cel" OR ABSTRACT:"axi-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 Axicabtagene ciloleucel, not a curated reading list.
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 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-1, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, ZUMA-7.
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, LYSA (The Lymphoma Study Association), Cytokine release syndrome and ICANS: grading and management.
Shares Jason R. Westin, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting.
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), POD24: progression of follicular lymphoma within two years, and why it changes the plan.
Shares ZUMA-5, Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial, POD24: progression of follicular lymphoma within two years, and why it changes the plan, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting.
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.