On May 26, Iovance Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its biologics license application for the novel tumor-infiltrating lymphocyte therapy lifileucel in patients with advanced melanoma whose tumors progressed after standard treatments. The FDA assigned November 25, 2023, as the target action date for a decision under the Prescription Drug User Fee Act. The company noted that the FDA previously granted lifileucel a Regenerative Medicine Advanced Therapy designation, representing the medication’s potential to address an unmet need in this patient population. In the C-144-01 trial—results of which were presented at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting—researchers demonstrated positive clinical outcomes with lifileucel for patients with advanced melanoma who experienced disease progression on or after prior anti–PD-1/PD-L1 therapy and targeted therapy. According to Iovance, if the application for lifileucel receives accelerated approval, “the randomized phase III TILVANCE-301 trial (ClinicalTrials.gov identifier NCT05727904) in front-line advanced melanoma can serve as the confirmatory study to support full approval.” Commenting on the FDA’s action, Frederick Vogt, PhD, JD, Interim President and Chief Executive Officer of Iovance Biotherapeutics, said, “The [biologics license application] acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor. The FDA’s commitment to a 6-month Priority Review validates the … urgency for [the therapy] for patients with advanced melanoma.”
June 01, 2023