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Ciltacabtagene autoleucel is a one-time BCMA CAR-T for myeloma that, in CARTITUDE-4, cut the risk of death by about 45% compared with standard regimens.
Approved 2022 (≥4 lines) and 2024 (≥1 prior line, lenalidomide-refractory; CARTITUDE-4 with OS benefit HR 0.55). A third of patients in CARTITUDE-1 remain progression-free at 5 years without maintenance. Delayed neurotoxicity (parkinsonism) and secondary malignancies are rare but notable. Legend Biotech/Johnson & Johnson.
Two BCMA-binding VHH domains, 4-1BB costimulation; lentiviral. Connects to BCMA.
1.Patient's T cells are collected by leukapheresis
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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 Q2056.
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 TA889. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2017-12-21 | Legend Biotech to Johnson & Johnson LCAR-B38M / JNJ-4528, later ciltacabtagene autoleucel (Carvykti) | Co-development | $350m | not disclosed | source |
Breakthrough Therapy designation source
Relapsed/refractory myeloma after ≥4 lines (CARTITUDE-1) source
Class boxed warning for T-cell malignancies source
Relapsed myeloma after ≥1 prior line, lenalidomide-refractory (CARTITUDE-4) source
REMS requirements removed for CAR-T class source
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Relapsed/refractory myeloma ≥4 lines |
| US | 2024 | Relapsed myeloma after ≥1 line, lenalidomide-refractory |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 78% | 3% |
| Neutropenia (grade 3+) | - | 95% |
| Hypogammaglobulinaemia | 94% | 9% |
| Infections (grade 3+) | - | 24% |
| ICANS | 7% | 0.5% |
| Parkinsonism / movement disorders | 1% | 0% |
| Secondary haematological malignancies | 3% | - |
CARTITUDE-4, n=188. 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | $465,000 per infusion (list price at launch, 2022; 2026 list higher) | janssencarepath.com |
| United Kingdom | NICE: recommended for relapsed myeloma after ≥1 line, lenalidomide-refractory (2025) | 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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CARTITUDE-4 is the first randomised trial to show that a CAR-T improves survival in myeloma, and it moved cilta-cel into second-line use (FDA approval 2024). For patients whose disease returns after first-line lenalidomide, a one-off cell therapy now competes with continuous drug combinations. Capacity, cost and the need for bridging therapy still limit who actually receives it.
CARTITUDE-1 showed that a single CAR-T infusion can put late-stage myeloma into deep, multi-year remission, leading to FDA approval of cilta-cel in 2022 for heavily pretreated disease. It set the efficacy bar for BCMA-directed therapy and motivated moving CAR-T earlier (CARTITUDE-4). Late neurological toxicity and secondary malignancies remain the safety questions.
Query for this drug: (TITLE:"Ciltacabtagene autoleucel" OR ABSTRACT:"Ciltacabtagene autoleucel" OR TITLE:"Carvykti" OR ABSTRACT:"Carvykti" OR TITLE:"cilta-cel" OR ABSTRACT:"cilta-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 Ciltacabtagene autoleucel, not a curated reading list.
Shares Yale University Open Data Access (YODA) Project, A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind, BCMA expression, IUCT Oncopole (Institut Universitaire du Cancer de Toulouse).
Shares Full refund for CAR-T if the patient has not responded at three months, Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product, Pay-for-cure contracts: instalment payments for curative therapies contingent on durable remission, Outcome-based annuity payments for potentially curative one-time therapies.
Shares BCMA expression, Autologous CAR-T manufacturing, batch by batch, BCMA, Relapsed or refractory multiple myeloma.
Shares A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma, A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind, Plasma cell leukaemia, Relapsed or refractory multiple myeloma.
Shares CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, BCMA, Relapsed or refractory multiple myeloma, Manufacturing cost and time for living and radioactive medicines.
Shares Outcome-based annuity payments for potentially curative one-time therapies, CARTITUDE-4, BCMA, Manufacturing cost and time for living and radioactive medicines.
Shares A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, CARTITUDE-6, A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind, CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy.
Shares BCMA expression, Newly diagnosed multiple myeloma, transplant-eligible, Relapsed or refractory multiple myeloma, Multiple myeloma.