Oncology Drug Reference Sheet: Lifileucel

June 25, 2024 by Madeline Johnston MSN, RN, OCN®

On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved the first tumor-infiltrating lymphocyte (TIL) cancer therapy for metastatic melanoma, lifileucel (Amtagvi™). Patients in the drug’s clinical trial experienced (https://doi.org/10.1200/jco.21.00612) a significant decrease in tumor burden, and the median overall survival was 17.4 months.

This ONS resource was produced for educational purposes only. Refer to the full lifileucel prescribing information (https://www.fda.gov/media/176417/download?attachment=) for all details. 

ClassificationTumor-derived autologous T-cell immunotherapy; tumor-infiltrating lymphocyte therapy
Mechanism of ActionLifileucil’s exact mechanism of action is unknown. In general, TIL therapies use T cells collected directly from the tumor and the cells are manufactured with the drug interleukin-2 (IL-2) to create cells that easily identify, navigate to, and fight the cancer specifically.
IndicationAdults diagnosed with metastatic or unresectable melanoma who have previously been treated with an anti–PD-1 antibody or a BRAF inhibitor, with or without MKI inhibitor if positive for a BRAF V600 variant.
Dosing, Frequency, and Duration
  • A single dose contains between 7.5 × 109 and 72 × 109 cells divided into four individual infusion bags of 100–125 ml each, housed in protective metal cassettes.
  • The treatment is for autologous use only; patient information must match identifiers on drug cassettes and infusion bags.
  • Administer in an inpatient hospital setting with access to cardiopulmonary support or critical care.
  • Preadministration: 
    • Two days prior to infusion, administer lymphodepleting cyclophosphamide and fludarabine via IV.
    • Infuse lifileucel 24–96 hours following the final dose of fludarabine.
    • Premedicate with diphenhydramine 30–60 minutes prior to lifileucel infusion. 
  • During administration:
    • Thaw and administer one bag of lifileucel at a time if more than one bag is provided.
    • Infuse 1 ml per minute for the first 5 minutes, then increase to 5–10 ml per minute thereafter.
    • After infusing the final bag, rinse the tubing and flush with normal saline at the same rate to ensure the entire product was given.
  • Postadministration:
    • 3–24 hours post infusion, administer IV IL-2 every 8–12 hours for a maximum of six doses to bolster the action of manufactured T cells. 
RouteIV infusion
Safe HandlingLifileucel does not meet the definition of a hazardous drug; however, no carcinogenicity or genotoxicity studies have been performed and its effects on fertility are unknown. Follow institutional handling precautions and local biosafety regulations to prevent infectious disease transmission.

Black box warnings  

  • Cardiopulmonary and renal impairment
  • Prolonged severe cytopenia
  • Severe infection 
  • Treatment-related mortality

Other warnings 

  • Hypersensitivity reaction


  • Severe cytopenias (including thrombocytopenia, lymphopenia, neutropenia, and leukopenia) lasting for 30 days or longer occurred in 45.5% of patients in lifileucel’s clinical trials.
  • Infection of any grade, including severe, life-threatening, or fatal, occurred in 26.9% of patients.


  • Tachycardia, atrial fibrillation, arrhythmia, acute myocardial infarction, cardiac ventricular thrombosis, cardiomyopathy, QT prolongation, and other cardiac disorders occurred in 9% of patients.


  • Acute reactions (e.g., fever, rigors, chills, tachycardia, rash, hypotension, dyspnea, cough, chest tightness, wheezing) generally occurred and resolved within one day of infusion.

Multisystem organ hemorrhage

  • In the treatment’s clinical trials, intrabdominal and intracranial hemorrhage was associated with two deaths.
  • Patients with thrombocytopenia must not use anticoagulants and must be monitored closely.

Additional monitoring

  • Signs of respiratory failure
  • Signs of acute renal injury or failure
  • Diarrhea, nausea, or vomiting
  • Laboratory abnormalities (e.g., thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia, hypophosphatemia)
  • Monitor patients’ baseline cardiopulmonary and renal status, perform pregnancy testing, and review patients’ blood panels. 
  • Test patients for chronic viral infection, including cytomegalovirus, hepatitis B or C, and HIV.
  • Confirm lymphodepletion with cyclophosphamide and fludarabine.
  • Premedicate patients with diphenhydramine 30–60 minutes prior to infusion.
  • Do not use a leukocyte depleting filter during administration.
  • Avoid systemic steroids, which may impede lifileucel’s effect.
  • Patients must be hospitalized before, during, and after administration.
  • Ensure IL-2 is available prior to lifileucel administration.
  • Verify patient’s identity and match identifiers to the drug cassettes and infusion bags.
  • Thaw and administer one bag at a time. Use room temperature water and break up clumps by inverting or massaging the bag. Inspect the bag for signs of leakage.
  • Monitor patient for signs of hypersensitivity and treat as needed. 
  • Give six doses of IL-2 to enhance the efficacy of the cellular product.
  • Closely monitor patients for hemorrhage, hypersensitivity reactions, and infection.
  • Educate patients about possible side effects of treatment.
  • Instruct patients to report symptoms such as:
    • Diarrhea
    • Fast or irregular heartbeat
    • Low blood pressure
    • Rash
    • Signs of bleeding
    • Signs of infection (e.g., fever, chills, fatigue, low white blood cell count)
  • Remind patients to remain within a two-hour drive of the treatment site for several weeks after treatment.
Patient Resources
Healthcare Professional Resources
Other Resources

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