TM Owner Iovance Biotherapeutics
Lifileucel TIL Therapy 0.75-7.2×10^10 viable cells Infusion
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Indications & Clinical Uses
- No medicine is marketed under the name 'Lifileucel TIL Therapy'; the approved brand for lifileucel is AMTAGVI, a tumour-infiltrating lymphocyte (TIL) cell therapy from Iovance Biotherapeutics, and the information here comes from the AMTAGVI US prescribing information.
- Iovance withdrew its European marketing authorisation application and the European Medicines Agency lists Amtagvi as withdrawn on 22 July 2025, so it is not authorised in the European Union; it remains available in the United States under the FDA accelerated approval granted in February 2024.
- Amtagvi is indicated for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if the tumour is BRAF V600 mutation-positive, with a BRAF inhibitor with or without a MEK inhibitor.
- It is a one-time, individually manufactured product grown from the patient's own tumour and given only in hospital by specialists.
Side Effects
- AMTAGVI (lifileucel) carries a BOXED WARNING covering treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary and renal impairment.
- Fatal reactions, including internal organ haemorrhage and acute kidney failure, occurred in about 7.5% of patients.
- Severe low blood counts lasting beyond 30 days affected 45.5%, so filgrastim is started the day after infusion and continued until the neutrophil count recovers, and severe infections occurred in 13.5%.
- The most common side effects, affecting more than 1 in 5 people, are chills (75.6%), fever (60.9%), tiredness (55.8%), fast heartbeat (47.4%), diarrhoea (46.8%), febrile neutropenia (46.8%), swelling (42.3%), rash, low blood pressure, hair loss, infection, low oxygen levels and breathlessness.
- Much of this burden comes from the lymphodepleting chemotherapy and the interleukin-2 given alongside the cells.
- Report fever, bleeding, breathlessness, reduced urine output or confusion to your team immediately.
Precautions & Warnings
- AMTAGVI is given only in an inpatient hospital setting where an intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine are available.
- Treatment starts with surgical removal of a tumour so the cells can be grown, then lymphodepleting chemotherapy with cyclophosphamide 60 mg/kg intravenously daily for 2 days with mesna, followed by fludarabine 25 mg/m2 daily for 5 days.
- Paracetamol and an antihistamine are given 30 to 60 minutes beforehand, then a single intravenous infusion of 7.5 to 72 billion viable cells in 1 to 4 patient-specific bags.
- Beginning 3 to 24 hours later, up to 6 doses of interleukin-2 600,000 IU/kg are given every 8 to 12 hours.
- Cardiopulmonary and renal function are monitored throughout and patients stay in hospital until serious reactions resolve, then remain close to the centre for several weeks.
- The product is patient-specific and must never be given to another person.
- It is stored in the vapour phase of liquid nitrogen at or below minus 150°C.
Avoid Interactions
- AMTAGVI is a living cell product, so conventional drug interaction studies do not apply, but what is taken around the treatment matters a great deal.
- Systemic corticosteroids must be avoided except where a life-threatening reaction requires them, because corticosteroids can destroy the infused lymphocytes and reduce the effect of the therapy; tell your team about any steroid you use, including inhalers and eye drops.
- Other immunosuppressant and antiproliferative medicines should not be started without specialist advice.
- Live vaccines are not recommended before lymphodepleting chemotherapy or until immune recovery.
- Medicines that add to kidney or cardiovascular strain, including nephrotoxic antibiotics and non-steroidal anti-inflammatory drugs, are used cautiously alongside interleukin-2.
- The cell suspension must not be mixed with, or infused through the same line as, any other medicine.
- Tell your care team about every prescription medicine, over-the-counter product, herbal remedy and supplement you take before lymphodepletion begins.
References
Frequently Asked Questions
Lifileucel, marketed as Amtagvi, is a one-time tumour-infiltrating lymphocyte therapy for adults with unresectable or metastatic melanoma that has progressed after a PD-1 blocking antibody and, if the tumour is BRAF V600 positive, after a BRAF inhibitor. The cells are grown from the patient's own tumour.
A tumour is removed surgically and the T cells inside it are grown for about a month. You then receive lymphodepleting chemotherapy, a single intravenous infusion of Amtagvi (lifileucel) in 1 to 4 bags, and up to 6 doses of interleukin-2. All of this happens in hospital.
Chills, fever, tiredness, fast heartbeat, diarrhoea, febrile neutropenia, swelling, rash, low blood pressure and breathlessness affect more than 1 in 5 people given Amtagvi (lifileucel). Its boxed warning covers treatment-related deaths, prolonged severe low blood counts, severe infection, and heart, lung and kidney problems.
Avoid systemic corticosteroids unless your team prescribes them for a life-threatening reaction, because steroids can destroy the infused lifileucel cells. Live vaccines are not given before lymphodepleting chemotherapy or until your immune system recovers. Tell your team about every medicine, including inhalers, eye drops and herbal products.
You stay in hospital until serious reactions settle, then remain close to the treatment centre for several weeks. Filgrastim starts the day after the Amtagvi (lifileucel) infusion and continues until neutrophils recover. Heart, lung and kidney function and blood counts are monitored closely throughout.
No. Iovance withdrew the European marketing authorisation application and the European Medicines Agency listed Amtagvi (lifileucel) as withdrawn on 22 July 2025, so it is not authorised in the European Union. It remains available in the United States under the FDA accelerated approval granted in February 2024.
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