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First TIL Therapy Approved by the FDA

February 16, 2024

The FDA granted accelerated approval to Iovance Therapeutics’ lifileucel (Amtagvi) to treat inoperable or metastatic melanoma, making it the first and only one-time tumor-infiltrating lymphocyte (TIL) therapy to be greenlighted for solid tumors. Lifileucel is manufactured by collecting and expanding a patient’s unique T cells from part of their tumor and then infusing them into that patient to fight the cancer. The approval was based on results of the C-144-01 clinical trial in patients previously treated with anti–PD-1 therapy and, if BRAFV600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Among 73 adults who received the recommended dose, 31.5% achieved an objective response. After 18.6 months, the median duration of response had not been reached, but 43% of responses had lasted at least 12 months. For the full story, read "Groundbreaking TIL Therapy OK'd for Melanoma." 

 

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