Iovance Biotherapeutics completes BLA submission for lifileucel

Iovance Biotherapeutics announced it has completed its rolling Biologics License Application submission to the U.S. Food and Drug Administration for lifileucel. Lifileucel is a tumor infiltrating lymphocyte therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options."