{"entity":{"id":"lifileucel","kind":"drug","name":"Lifileucel","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Lifileucel","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lifileucel"}],"tags":[],"related":[],"cancers":["melanoma","nsclc","advanced-melanoma"],"sections":[],"technologies":["til-therapy"],"targets":[],"drugs":[],"companies":["iovance"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07288203","nct06481592"],"people":["inge-marie-svane"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Amtagvi","modality":"TIL cell therapy","mechanism":"Autologous TILs expanded ex vivo with IL-2; lymphodepletion; high-dose IL-2 after infusion.","approvals":[{"region":"US","year":2024,"indication":"Unresectable/metastatic melanoma after anti-PD-1 (and BRAF/MEK if applicable)"}],"mechanismSteps":["Tumour is surgically resected and shipped to the manufacturing site","Tumour-infiltrating lymphocytes are expanded ex vivo with IL-2 over ~3 weeks","Patient receives lymphodepleting chemotherapy","Billions of polyclonal tumour-reactive T cells are infused","IL-2 supports engraftment and expansion","TILs recognise neoantigens and kill tumour cells"],"dosing":{"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","modifications":"IL-2 held for hypotension, arrhythmia, or organ dysfunction","monitoring":"Inpatient management; cardiac, pulmonary, renal function; cytopenias; infections","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Thrombocytopenia"},{"event":"Chills"},{"event":"Pyrexia"},{"event":"Anaemia"},{"event":"Febrile neutropenia"},{"event":"Hypotension"},{"event":"Treatment-related mortality","note":"Boxed warning; deaths related to lymphodepletion/IL-2 reported"}],"access":[{"country":"US","listPrice":"$515,000 per treatment (list price at launch, 2024)","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.iovancecares.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"EU","reimbursement":"EMA approved 2025; national pricing pending","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-05","type":"filing","region":"US","note":"BLA submitted","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-02-16","type":"accelerated-approval","region":"US","note":"Accelerated approval, unresectable/metastatic melanoma after anti-PD-1 (C-144-01): first TIL therapy The confirmatory requirement was still open 2.6 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor."},{"date":"2025-06","type":"approval","region":"EU","note":"Conditional marketing authorisation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/lifileucel/","neighbours":{"cancer":[{"id":"acral-melanoma","kind":"cancer","name":"Acral melanoma","route":"/cancers/acral-melanoma/"},{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"mucosal-melanoma","kind":"cancer","name":"Mucosal melanoma","route":"/cancers/mucosal-melanoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"car-t-manufacturing-process","kind":"technology","name":"Autologous CAR-T manufacturing, batch by batch","route":"/technologies/car-t-manufacturing-process/"},{"id":"til-therapy","kind":"technology","name":"TIL therapy","route":"/technologies/til-therapy/"}],"company":[{"id":"iovance","kind":"company","name":"Iovance Biotherapeutics","route":"/companies/iovance/"}],"trial":[{"id":"nct06481592","kind":"trial","name":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.","route":"/trials/nct06481592/"},{"id":"nct07288203","kind":"trial","name":"A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma","route":"/trials/nct07288203/"},{"id":"c-144-01","kind":"trial","name":"C-144-01","route":"/trials/c-144-01/"}],"person":[{"id":"amod-sarnaik","kind":"person","name":"Amod A. Sarnaik","route":"/people/amod-sarnaik/"},{"id":"inge-marie-svane","kind":"person","name":"Inge Marie Svane","route":"/people/inge-marie-svane/"},{"id":"john-haanen","kind":"person","name":"John Haanen","route":"/people/john-haanen/"},{"id":"steven-rosenberg","kind":"person","name":"Steven A. Rosenberg","route":"/people/steven-rosenberg/"}],"institution":[{"id":"moffitt","kind":"institution","name":"Moffitt Cancer Center","route":"/institutions/moffitt/"}],"pairing":[{"id":"io-then-til","kind":"pairing","name":"PD-1 failure → TIL therapy","route":"/pairings/io-then-til/"}],"roadmap":[{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"},{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"}],"idea":[{"id":"idea-bio2-til-reactivity-selection","kind":"idea","name":"Select patients for cell therapy by whether their tumour holds reactive T cells","route":"/ideas/idea-bio2-til-reactivity-selection/"},{"id":"idea-bio1-organoid-cell-therapy-potency","kind":"idea","name":"Use patient organoids to check a cell therapy will work before infusing it","route":"/ideas/idea-bio1-organoid-cell-therapy-potency/"}],"paper":[{"id":"paper-c-144-01-lifileucel-melanoma-jco-2021","kind":"paper","name":"C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed","route":"/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/"},{"id":"paper-rohaas-til-vs-ipilimumab-nejm-2022","kind":"paper","name":"Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma","route":"/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/"}],"drug":[{"id":"tacquell","kind":"drug","name":"Tacquell (autologous melanoma-derived tumour-infiltrating lymphocytes)","route":"/drugs/tacquell/"}],"term":[{"id":"immune-surveillance-immunoediting","kind":"term","name":"Immune surveillance and cancer immunoediting","route":"/terms/immune-surveillance-immunoediting/"}]}}