First Cancer TIL Therapy (Lifileucel) Gets FDA Approval for Advanced Melanoma

In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes (TILs). Announced on February 16, 2024, the agency’s decision also makes lifileucel the first cellular therapy to be approved for a solid tumor, the skin cancer melanoma. The agency’s accelerated approval covers the use of lifileucel for people with advanced melanoma that has gotten worse after treatment with certain immunotherapy drugs or targeted therapies. As is the case with CAR T-cell therapy, another type of cellular therapy, lifileucel is made using a patient’s own T cells. And with both therapies, the cells are collected at the hospital where the patient is being treated but are sent away to be manufactured into the final treatment. But there’s a key difference between TILs and CAR T-cell therapies. For the approved CAR T-cell therapies, the T cells are collected from a patient’s circulating blood. For TIL therapy, by contrast, the T cells are collected from the patient’s tumor. 

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