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Lifileucel (Amtagvi) is a first-in-class, autologous tumor-infiltrating lymphocyte (TIL) cell therapy developed by Iovance Biotherapeutics. It is indicated for adult patients with unresectable or metastatic melanoma who have progressed following treatment with a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The therapy involves a one-time infusion of a patient's own T-cells that have been harvested from a resected tumor, expanded ex vivo in a centralized manufacturing facility, and then re-infused following a non-myeloablative lymphodepletion regimen. Lifileucel works by leveraging the polyclonal nature of TILs to recognize a diverse array of patient-specific tumor neoantigens, overcoming immune escape mechanisms common in solid tumors. It is the first cellular therapy approved by the FDA for a solid tumor malignancy.
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