Axicabtagene ciloleucel
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.
Approved 2017 (ZUMA-1; 5-year OS ~43%), 2022 second-line for early relapse (ZUMA-7, OS benefit), and follicular lymphoma. Kite/Gilead. CD28 costimulation gives fast expansion and more neurotoxicity than 4-1BB products.
1.Patient's T cells are collected by leukapheresis
- Route
- Single IV infusion after lymphodepletion
- Schedule
- 2 × 10⁶ CAR+ T cells/kg (max 2 × 10⁸); cyclophosphamide 500 mg/m² + fludarabine 30 mg/m² days −5 to −3
- Dose modifications
- Tocilizumab ± steroids for CRS; steroids for ICANS; prophylactic steroids permitted
- Monitoring
- Daily monitoring for 7 days (outpatient permitted with rapid access), then twice weekly for 4 weeks; cytopenias, infections, B-cell aplasia
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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 Q2041.
- 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.
- List price
- $373,000 per one-time treatment, launch list price
National Cancer Institute, Cancer Currents, October 2017 (reporting Kite/Gilead's announced price) (2017). Net prices after rebates are usually lower.
- Assistance programmes
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.
- Appraised for
- Relapsed or refractory DLBCL or PMBCL after 2 or more systemic therapies
- Notes
- Moved to routine commissioning in TA872 (2023); second-line DLBCL (ZUMA-7) recommended in TA895 (2023). Delivered at designated CAR-T centres.
- 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 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.
- 18 Oct 2017ApprovalUS
Relapsed/refractory large B-cell lymphoma after ≥2 lines (ZUMA-1): second CAR-T ever approved source
- 5 Mar 2021ApprovalUS
Relapsed/refractory follicular lymphoma (ZUMA-5) source
- 1 Apr 2022ApprovalUS
Second-line LBCL refractory or relapsed within 12 months (ZUMA-7) source
- 19 Jan 2024Label changeUS
Class boxed warning for T-cell malignancies source
Approvals
| 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.
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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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.
Latest papers
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