Iovance Biotherapeutics, Inc. announced the U.S. Food and Drug Administration (FDA), because of resource constraints, requires additional time to complete the Priority Review of Iovance's Biologics License Application (BLA) for lifileucel. The FDA is also engaged and has expressed no concerns on the status of the TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date. Lifileucel, if approved, will be the first and only TIL therapy for patients with advanced melanoma, as well as the first one-time cell therapy for a solid tumor cancer.

Lifileucel is an individualized therapy intended 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. The FDA accepted the BLA for lifileucel in May 2023 under Priority Review and previously granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma.

The extension of the PDUFA date does not impact the Priority Review status or RMAT designation. The BLA submission for lifileucel is supported by positive data from the C-144-01 clinical trial in patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. If lifileucel receives accelerated approval, the randomized Phase 3 TILVANCE-301 trial in frontline advanced melanoma can serve as the confirmatory study to support full approval.

TILVANCE-301 is expected to be well underway at the time of approval.