The USFDA has approved lifileucel intravenous infusion for treating adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. It is the first individualized T-cell therapy to receive FDA approval for a solid tumor cancer. Clinical trial The FDA approval is based on the safety and efficacy outcomes of the C-144-01 clinical trial. This global, multicenter study assessed lifileucel in advanced melanoma patients previously treated with anti-PD-1 therapy and targeted therapy, as applicable.
Lifileucel exhibited significant and lasting responses, with 31.5% achieving an objective response in the primary efficacy analysis set of 73 patients. The median duration of response was not reached at 18.6 months follow-up, and 43.5% had responses lasting over 12 months. Dosage and administration · Provided in 1 to 4 infusion bag(s) containing 100 mL to 125…
