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

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.  ...