Iovance Biotherapeutics Completes BLA Submission For Lifileucel In Advanced Melanoma

Shares of Iovance Biotherapeutics, Inc. (IOVA) gained over 10% in extended session on Friday after the company announced that it completed Biologics License Application (BLA) submission for Lifileucel in advanced melanoma.

Iovance Biotherapeutics, a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling BLA submission to the U.S. Food and Drug Administration for lifileucel.

Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced (unresectable or metastatic) 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.

CEO Frederick Vogt 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."

"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," he added.

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