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lifileucel (Amtagvi)
Indications:
- unresectable or metastatic melanoma (accelerated approval 2024)
- previously treated with a PD-1 blocking antibody
- if BRAF V600 mutation positive, also treated with a BRAF inhibitor with or without a MEK inhibitor
Dosage:
- dose is 7.5-72 x 10E9 viable cells suspended in 1-4 patient infusion bags
- administer in hospital setting with an intensive care unit
- administer lymphocyte-depleted regimen prior to lifileucel
- do not use leukocyte depleting filter when administering lifileucel
- premedicate with acetaminophen, or equivalent, & diphenhydramine, or another H1-antihistamine
- administer IL-2 (aldesleukin) after infusion of lifileucel
Adverse effects:
- in order of frequency
- chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, dyspnea
- severe
- prolonged severe cytopenia
- internal organ hemorrhage
Mechanism of action:
- autologous T-cell immunotherapy
General
chimeric antigen-receptor (CAR) T-cell therapy; tisagenlecleucel; CTL019 (Kymriah)
References
- Highlights of Prescribing Information
AMTAGVI (lifileucel) suspension for intravenous infusion
https://www.fda.gov/media/176417/download?attachment