Lifileucel
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-LIFILEUCEL |
|---|---|
| Type | Drug |
| Aliases | AmtagviLN-144lifileucel-tarmunileucelЛіфілейцел |
| Status | reviewed 2026-04-27 | pending_clinical_signoff |
| Diseases | DIS-MELANOMA |
| Sources | SRC-ESMO-MELANOMA-2024 SRC-NCCN-MELANOMA-2025 |
Drug Facts
| Class | Autologous tumor-infiltrating lymphocyte (TIL) cell therapy |
|---|---|
| Mechanism | Patient-specific autologous polyclonal cell-therapy product manufactured ex vivo from a fresh resected tumor specimen (typically a single ≥1.5 cm cutaneous, subcutaneous, lymph-node, or visceral metastasis). The tumor is enzymatically dissociated; endogenous tumor-infiltrating lymphocytes (TILs — predominantly CD8+ effector T cells with native polyclonal TCR repertoire recognizing patient-unique tumor neoantigens) are expanded over ~22 days using interleukin-2 (IL-2) and an OKT3 anti-CD3 stimulus, then cryopreserved and shipped back. Treatment requires three steps: (1) non-myeloablative lymphodepleting chemotherapy (cyclophosphamide + fludarabine) to deplete suppressive Tregs and create homeostatic cytokine sinks; (2) single IV infusion of the expanded TIL product (target 7.5–72 × 10⁹ viable cells); (3) short-course high-dose IL-2 (aldesleukin 600,000 IU/kg IV q8-12 h for up to 6 doses)... |
| Typical dosing | Single intravenous infusion of 7.5 × 10⁹ to 72 × 10⁹ viable TIL cells (median ~21 × 10⁹) administered after non-myeloablative lymphodepletion: cyclophosphamide 60 mg/kg/day IV × 2 days (Days -7 and -6), then fludarabine 25 mg/m²/day IV × 5 days (Days -5 through -1). TIL infusion on Day 0. Post-infusion IL-2 support: aldesleukin 600,000 IU/kg IV every 8-12 hours starting 3-24 h after TIL infusion, for up to 6 doses (often fewer due to cumulative IL-2 toxicity — capillary leak, hypotension, oliguria). Single course; no maintenance. Manufacturing takes ~22 days from tumor harvest to shipment, with bridging therapy as needed. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Treatment-related mortality (~7-8% in trial cohorts; multifactorial — lymphodepletion, IL-2, immune effects)
- Prolonged severe cytopenia (lymphodepletion + cellular product)
- Severe infection (fungal, bacterial, viral; including opportunistic)
- Cardiopulmonary disorders (IL-2-mediated capillary leak, arrhythmia, MI)
- Renal failure (IL-2-mediated)
Notes
First cell-therapy approved for any solid tumor. Logistics resemble CAR-T but more demanding: requires fresh tumor harvest (single accessible ≥1.5 cm lesion; surgical or interventional- radiology biopsy not adequate — needs gross tissue), centralized manufacturing (~22 days), bridging therapy during manufacturing, in-patient lymphodepletion + TIL infusion + IL-2 administration in ICU-capable cell-therapy center, prolonged cytopenia recovery, and ~7-8% treatment-related mortality. Eligibility per FDA label: ECOG 0-1, adequate organ function, anti-PD-1 ± BRAFi+MEKi failure, accessible lesion for harvest, anticipated tolerance of IL-2. Patient selection is critical — frail patients have prohibitive mortality risk. UA access in MVP effectively zero; the only realistic pathway is cross-border referral to a US (or eventually EU) Iovance-accredited center via 'Лікування за кордоном' (наказ МОЗ 988) with private / charitable funding — total cost USD 500K-1M. Listed for completeness; rule-engine inclusion as a referral-only option in melanoma post-anti-PD-1.
Used By
Regimens
REG-LIFILEUCEL-TIL-MELANOMA- Lifileucel TIL therapy (Amtagvi, melanoma 3L+)