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World’s first TIL therapy among FDA’s five February PDUFA dates


An approval for Iovance’s lifileucel would mark the entry of immune cell therapies into solid tumors

By Gunjan Ohri, Data Content Analyst, and Selina Koch, Executive Editor

February 1, 2024 1:48 AM UTC

The five disclosed PDUFA dates on FDA’s roster in February include a decision on Iovance’s tumor-infiltrating lymphocyte (TIL) therapy lifileucel. An approval would be the first for the TIL modality and give melanoma patients a cell therapy option.

CAR T therapies may have beat TIL therapies to the market, but they have yet to make meaningful inroads into solid tumors. That’s because the initial targets CAR T cells have been engineered to bind are also expressed on non-cancerous cells, leading to the death of the healthy cells. That’s tolerable when the healthy cells are B cells that can be replaced relatively quickly; it’s less so in solid tissues with less regenerative power.