First TIL Therapy Approved by the FDA
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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