Lifileucel

The specific mechanism of action of AMTAGVI (lifileucel) is unknown.

• AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of 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. This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14) ] .ICD-10: C43.9

• None.contraindicated

For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion. For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion. Administer AMTAGVI in an inpatient hospital setting with an intensive care facility ( 2.1 ) The AMTAGVI dose is between 7.5 × 10 9 and 72 × 10 9 viable cells ( 2.1 ) Administer a lymphodepleting regimen before infusion of AMTAGVI ( 2.2 ) Do NOT use a leukocyte depleting filter with AMTAGVI ( 2.2 ) Premedicate the patient with acetaminophen, or equivalent, and diphenhydramine, or another H1-antihistamine ( 2.2 ) Avoid prophylactic use of systemic corticosteroids ( 2.2 ) Administer entire dose of AMTAGVI ( 2.2 ) Administer IL-2 (aldesleukin) after infusion of AMTAGVI ( 2.2 ) See Full Prescribing Information for instructions on receipt, preparation, and administration of AMTAGVI ( 2.2 , 16 ) 2.1 Dose Administer in an inpatient hospital setting under the supervision of a physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available. AMTAGVI is provided as a single dose for infusion containing a suspension of tumor-derived T cells. The dose is supplied in 1 to 4 patient-specific IV infusion bag(s) in individual protective metal cassettes. Each dose contains 7.5 × 10 9 to 72 × 10 9 viable cells. 2.2 Administration AMTAGVI is for autologous use only. The patient's identity must match the patient identifiers on the AMTAGVI cassette(s) and infusion bag(s).

Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion ( 5.8 ) 5.1 Treatment-Related Mortality AMTAGVI is associated with treatment-related mortality. In the clinical trial, the treatment-related mortality rate was 7.5% (N=160), including 2 deaths during the lymphodepleting period, 6 deaths within 30 days, and 4 deaths 38 to 150 days following AMTAGVI administration. Adverse reactions associated with these deaths included severe infections (sepsis, pneumonia and encephalitis), internal organ hemorrhage (abdominal hemorrhage and intracranial hemorrhage), acute renal failure, acute respiratory failure, cardiac arrythmia, extensive ascites, liver injury, and bone marrow failure. Because clinical trials are conducted under widely varying conditions, treatment-related mortality rates observed in the clinical trials of a drug may not reflect the rates observed in practice. 5.2 Prolonged Severe Cytopenia Patients treated with AMTAGVI may exhibit Grade 3 or higher cytopenia for weeks or longer. Based on adverse event reporting, Grade 3 or higher cytopenia or pancytopenia which did not resolve to less than or equal to Grade 2 or lasted beyond 30 days post AMTAGVI infusion occurred in 45.5% of melanoma patients who received AMTAGVI. Prolonged cytopenia included thrombocytopenia (30.1%), lymphopenia (19.9%), neutropenia (17.3%), leukopenia (14.7%), and pancytopenia (1.3%). Monitor blood counts after AMTAGVI infusion. 5.3 Internal Organ Hemorrhage Patients treated with AMTAGVI may exhibit internal organ hemorrhage.

The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea. The serious adverse reactions included: Treatment-Related Mortality [see Warnings and Precautions (5.1) ] Prolonged Severe Cytopenia [see Warnings and Precautions (5.2) ] Internal Organ Hemorrhage [see Warnings and Precautions (5.3) ] Severe Infection [see Warnings and Precautions (5.4) ] Cardiac Disorder [see Warnings and Precautions (5.5) ] Respiratory Failure [see Warnings and Precautions (5.6) ] Acute Renal Failure [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Iovance Biotherapeutics, Inc. at 1-833-400-IOVA (4682) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary There are no available data with AMTAGVI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AMTAGVI. Therefore, AMTAGVI is not recommended for women who are pregnant, and pregnancy after AMTAGVI administration should be discussed with the treating physician. Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of AMTAGVI in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AMTAGVI and any potential adverse effects on the breastfed infant from AMTAGVI or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing The pregnancy status of women of child-bearing potential should be verified. Sexually active females of reproductive potential should have a pregnancy test prior to starting treatment with AMTAGVI. Infertility There are no data on the effect of AMTAGVI on fertility.

Metabolism

The proportion of unique TCR clonotypes from the AMTAGVI lots contributing to the peripheral blood TCR repertoire among infused patients was analyzed using a semi-quantitative polymerase chain reaction followed by next generation sequencing. The proportion of TCR clones that are composed of clonotypes identified in the product increases from a mean of 16% (n=125) at pre-infusion to 83% at Day 4 after AMTAGVI infusion.

1. 1Pyrexia3816%
2. 2Hypotension2711%
3. 3Chills208.4%
4. 4Hypoxia208.4%
5. 5Acute Kidney Injury197.9%
6. 6Cytokine Release Syndrome166.7%
7. 7Pancytopenia166.7%
8. 8Thrombocytopenia166.7%
9. 9Febrile Neutropenia156.3%
10. 10Nausea156.3%
11. 11Death145.9%
12. 12Malaise145.9%
13. 13Diarrhoea135.4%
14. 14Dyspnoea135.4%
15. 15Pleural Effusion135.4%

The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Lifileucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
  Recruiting · Phase 1 · Phase 2 · Interventional · 53 enrolled · Iovance Biotherapeutics, Inc.
  NCT05361174updated 2026-06-11
• SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
  Recruiting · Phase 3 · Interventional · 360 enrolled · Immatics US, Inc.
  NCT06743126updated 2026-06-10
• A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
  Recruiting · Phase 1 · Interventional · 30 enrolled · Memorial Sloan Kettering Cancer Center
  NCT05607095updated 2026-05-28
• Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
  Terminated · Phase 2 · Interventional · 225 enrolled · Iovance Biotherapeutics, Inc.
  NCT03645928updated 2026-05-15
• Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma
  Completed · Phase 2 · Interventional · 11 enrolled · University of Kansas Medical Center
  NCT06151847updated 2026-04-30
• Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
  Available · Expanded access · Iovance Biotherapeutics, Inc.
  NCT05398640updated 2026-04-20
• A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
  Active not recruiting · Phase 2 · Interventional · 100 enrolled · Iovance Biotherapeutics, Inc.
  NCT07288203updated 2026-04-20
• Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
  Active not recruiting · Phase 1 · Interventional · 40 enrolled · Iovance Biotherapeutics, Inc.
  NCT06566092updated 2026-04-06
• Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
  Recruiting · Phase 3 · Interventional · 670 enrolled · Iovance Biotherapeutics, Inc.
  NCT05727904updated 2026-04-03
• Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
  Completed · Phase 2 · Interventional · 220 enrolled · Iovance Biotherapeutics, Inc.
  NCT02360579updated 2026-03-25

Frequently asked questions

How does Lifileucel work?

The specific mechanism of action of AMTAGVI (lifileucel) is unknown.

What is Lifileucel used for?

According to FDA labeling, Lifileucel carries indications including: AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of 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. This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lifileucel?

Lifileucel is classified as Antineoplastic cell and gene therapy, Unknown Cellular or Molecular Interaction.

What are the brand names for Lifileucel?

Lifileucel is marketed under brand names including Amtagvi.

What are the contraindications for Lifileucel?

Lifileucel labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.