The biotechnology company Iovance Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has extended the target action date for the Priority Review of the company’s biologics license application for the novel tumor-infiltrating lymphocyte (TIL) therapy lifileucel to February 24, 2024, due to resource constraints. The initial target action date was extended under the Prescription Drug User Fee Act, and Priority Review will continue with several updates from the FDA—including that all preapproval inspections were successfully completed, there were no major review issues, and there were no plans to hold an advisory committee meeting. The company noted that if accelerated approval of lifileucel is achieved, the novel agent may be one of the first TIL therapies available for patients with advanced melanoma whose disease progressed after treatment with anti–PD-1/-L1 therapy. Further, the randomized phase III TILVANCE-301 trial may serve as additional evidence of the efficacy of lifileucel in this patient population. “Iovance and [the] FDA remain engaged to complete the review process as quickly as possible. We appreciate [the] FDA management’s efforts to expedite the remaining review so that we can bring lifileucel to critically ill patients with no other FDA-approved options after current standard of care,” concluded Frederick Vogt, PhD, JD, Interim President and Chief Executive Officer at Iovance Biotherapeutics.
September 27, 2023