Iovance Biotherapeutics (NASDAQ:IOVA) told investors that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma.
Its shares rallied 14% in early Tuesday trade to $8.44.
The biotechnology company said in a statement that the FDA granted lifileucel Priority Review and assigned November 25, 2023, as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).
Iovance explained that Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, noting that there are no FDA-approved therapies in this treatment setting.
“The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor,” Iovance interim president and CEO Frederick Vogt said.
“The FDA’s commitment to a six-month Priority Review validates the unmet need and urgency for new treatment options for patients with advanced melanoma who have progressed on or after standard-of-care therapies. I am grateful for the patients and physicians who took part in all our clinical trials, as well as the Iovance team for their outstanding work on our first BLA filing.”
The company said the FDA is not currently planning to hold an advisory committee meeting to discuss the application and, after a preliminary review, has not identified any potential review issues.
Contact the author at stephen.gunnion@proactiveinvestors.com