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BioWorld - Saturday, April 18, 2026
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Home » FDA clears first TIL therapy as Iovance wins accelerated nod in melanoma
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FDA clears first TIL therapy as Iovance wins accelerated nod in melanoma

Feb. 20, 2024
By Jennifer Boggs
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in 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
BioWorld Regulatory Cancer U.S. FDA

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