Lifileucel
Lifileucel was the first approved TIL therapy: the patient's own tumour-fighting immune cells are expanded to billions and given back.
Accelerated approval February 2024 for anti-PD-1-refractory advanced melanoma (C-144-01: ORR 31%; 5-year data show median DOR 36.5 months and ~30% of responders in ongoing response). Confirmatory TILVANCE-301 with pembrolizumab in first line. EU approval 2025. Trials in NSCLC, cervical, and endometrial cancer.
1.Tumour is surgically resected and shipped to the manufacturing site
- Route
- Single IV infusion after lymphodepletion
- Schedule
- 7.5 × 10⁹ to 72 × 10⁹ viable cells; cyclophosphamide 60 mg/kg ×2 and fludarabine 25 mg/m² ×5 before; IL-2 600,000 IU/kg every 8-12 h for up to 6 doses after
- Dose modifications
- IL-2 held for hypotension, arrhythmia, or organ dysfunction
- Monitoring
- Inpatient management; cardiac, pulmonary, renal function; cytopenias; infections
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)
Autologous TIL therapy; not a CAR-T so NCD 110.24 does not apply. Covered case by case by Medicare contractors as a reasonable and necessary FDA-approved biologic; the inpatient stay for lymphodepletion, infusion and high-dose IL-2 is paid under Part A.
- 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. Iovance reports broad payer policy coverage since 2024.
- Assistance programmes
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A) · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: lifileucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- May 2023Filing / dealUS
BLA submitted source
- 16 Feb 2024ApprovalUS
Accelerated approval, unresectable/metastatic melanoma after anti-PD-1 (C-144-01): first TIL therapy source
- Jun 2025ApprovalEU
Conditional marketing authorisation source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Unresectable/metastatic melanoma after anti-PD-1 (and BRAF/MEK if applicable) |
| Adverse event |
|---|
| Thrombocytopenia |
| Chills |
| Pyrexia |
| Anaemia |
| Febrile neutropenia |
| Hypotension |
| Treatment-related mortality |
Boxed warning; deaths related to lymphodepletion/IL-2 reported. 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 | $515,000 per treatment (list price at launch, 2024) | iovancecares.com |
| European Union | EMA approved 2025; national pricing pending | 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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This trial supplied the randomised proof that was missing for TIL therapy and showed academic centres can run cell-therapy phase 3 trials without industry. It supports TIL as a standard option after checkpoint inhibitor failure in melanoma and underpinned reimbursement in the Netherlands. The comparator, ipilimumab, is itself only modestly effective in this setting, and overall survival did not differ significantly.
Lifileucel proved that Steven Rosenberg's decades-old TIL concept could be industrialised into a licensed product and gave patients with checkpoint-refractory melanoma, who otherwise have few options, a chance of durable remission. It is the first cell therapy approved for any solid tumour. The treatment requires surgery to harvest tumour, hospitalisation for lymphodepletion and IL-2, and specialised centres, so its reach is limited.
Latest papers
topQuery for this drug: (TITLE:"Lifileucel" OR ABSTRACT:"Lifileucel" OR TITLE:"Amtagvi" OR ABSTRACT:"Amtagvi") 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 Lifileucel, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductAldesleukin (high-dose IL-2)
Shares Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, TIL therapy, Melanoma.
- PersonShari Pilon-Thomas
Shares Moffitt Cancer Center, TIL therapy, Melanoma.
- PersonPatrick Hwu
Shares Moffitt Cancer Center, TIL therapy, Melanoma.
- TermTumour-infiltrating lymphocytes (TILs)
Shares Select patients for cell therapy by whether their tumour holds reactive T cells, Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, TIL therapy.
- IdeaSwitch drugs at maximum response, not at relapse
Shares Moffitt Cancer Center, Melanoma, Non-small-cell lung cancer.
- InstitutionLeiden University Medical Center
Shares John Haanen, Cervical cancer, Melanoma.
- IdeaTreat the draining lymph node before removing it
Shares John Haanen, Head and neck squamous cell carcinoma, Melanoma.
- PersonTon Schumacher
Shares Select patients for cell therapy by whether their tumour holds reactive T cells, Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma.