# Lifileucel

Source: https://onco.cc/drugs/lifileucel/  
OnCo record `lifileucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Lifileucel was the first approved TIL therapy: the patient's own tumour-fighting immune cells are expanded to billions and given back.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Amtagvi
- Modality: TIL cell therapy
- Mechanism: Autologous TILs expanded ex vivo with IL-2; lymphodepletion; high-dose IL-2 after infusion.
- Approvals: US 2024: Unresectable/metastatic melanoma after anti-PD-1 (and BRAF/MEK if applicable)
- Dosing: Single IV infusion after lymphodepletion; 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

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Lifileucel
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lifileucel

## Connected records

- cancers: [Acral melanoma](https://onco.cc/cancers/acral-melanoma/), [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Cervical cancer](https://onco.cc/cancers/cervical/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Melanoma](https://onco.cc/cancers/melanoma/), [Mucosal melanoma](https://onco.cc/cancers/mucosal-melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [TIL therapy](https://onco.cc/technologies/til-therapy/)
- companies: [Iovance Biotherapeutics](https://onco.cc/companies/iovance/)
- trials: [A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.](https://onco.cc/trials/nct06481592/), [A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma](https://onco.cc/trials/nct07288203/), [C-144-01](https://onco.cc/trials/c-144-01/)
- people: [Amod A. Sarnaik](https://onco.cc/people/amod-sarnaik/), [Inge Marie Svane](https://onco.cc/people/inge-marie-svane/), [John Haanen](https://onco.cc/people/john-haanen/), [Steven A. Rosenberg](https://onco.cc/people/steven-rosenberg/)
- institutions: [Moffitt Cancer Center](https://onco.cc/institutions/moffitt/)
- pairings: [PD-1 failure → TIL therapy](https://onco.cc/pairings/io-then-til/)
- roadmaps: [Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR](https://onco.cc/roadmaps/cell-therapy-roadmap/), [Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity](https://onco.cc/roadmaps/immunotherapy-roadmap/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- ideas: [Select patients for cell therapy by whether their tumour holds reactive T cells](https://onco.cc/ideas/idea-bio2-til-reactivity-selection/), [Use patient organoids to check a cell therapy will work before infusing it](https://onco.cc/ideas/idea-bio1-organoid-cell-therapy-potency/)
- key papers: [C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed](https://onco.cc/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/), [Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma](https://onco.cc/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/)
- drugs: [Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)](https://onco.cc/drugs/tacquell/)
- terms: [Immune surveillance and cancer immunoediting](https://onco.cc/terms/immune-surveillance-immunoediting/)

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JSON: https://onco.cc/api/v1/entities/lifileucel.json