Amtagvi (Lifileucel) for Melanoma

Overview
Amtagvi is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with unresectable (cannot be removed by surgery) or metastatic melanoma (melanoma that has spread) who have previously been treated with a PD-1-blocking antibody. If the melanoma has a BRAF V600 mutation, the recipient must have also been treated with a BRAF inhibitor, with or without a MEK inhibitor. Amtagvi is also known by its drug name, lifileucel.

Amtagvi is a tumor-derived autologous T-cell immunotherapy. It works by using the recipient’s own T cells, which are modified and expanded outside the body, to target and destroy melanoma cells when re-infused into the person.

How do I take it?
Prescribing information states that Amtagvi is administered as an intravenous infusion in an inpatient hospital setting with access to intensive care facilities and specialists in cardiopulmonary and intensive care medicine. The treatment generally involves several steps, including a lymphodepleting regimen (which involves chemotherapy) before the infusion, premedication with acetaminophen and diphenhydramine, and administration of interleukin-2 (aldesleukin) after Amtagvi infusion. 

Side effects
Common side effects of Amtagvi, according to prescribing information, include chills, pyrexia (fever), fatigue, tachycardia (rapid heart rate), diarrhea, febrile neutropenia (low white blood cells with fever), edema (swelling), rash, hypotension (low blood pressure), alopecia (hair loss), infection, hypoxia (low oxygen levels), and dyspnea (difficulty breathing).

Rare but serious side effects may include treatment-related mortality, prolonged severe cytopenia (low blood cell counts), severe infections, cardiopulmonary impairment (heart and lung problems), renal impairment (kidney problems),  internal hemorrhage (bleeding), and hypersensitivity reactions (allergic reactions). 

For more information about this treatment, visit:

Label: Amtagvi — Lifileucel Suspension — DailyMed

Lifileucel Injection — MedlinePlus