RE:CD8+ TiLs and T-cell exhaustionSeptember 2023 - The FDA has extended the priority review period for the biologics license application (BLA) seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.
the updated PDUFA date is February 24, 2024.
The BLA was supported by data from cohort 2 (n = 66) and cohort 4 (n = 87) of the phase 2 C-144-01 trial (NCT02360579). Pooled data from both cohorts showed that patients who had progressed on or after immune checkpoint inhibitor therapy or, when appropriate, targeted BRAF/MEK inhibitor therapy achieved an overall response rate (ORR) of 31.4% (95% CI, 24.1%-39.4%). Nine patients experienced a complete response (CR), and 39 patients had a partial response (PR).