Iovance Initiates Biologics License Application Submission for Lifileucel in Advanced Melanoma

First TIL Therapy BLA Submission Initiated with U.S. Food and Drug Administration

Complete BLA Submission on Track for Fourth Quarter 2022

 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that it has initiated a rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel, a tumor infiltrating lymphocyte (TIL) therapy, in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. There are no FDA approved therapies in this treatment setting.

https://finance.yahoo.com/news/iovance-biotherapeutics-initiates-biologics-license-113000028.html