Iovance Bio Gets Priority Review for Melanoma BLA

FDA has accepted for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The company is seeking accelerated approval from FDA, which has set a user fee review action target date of 11/25. The agency told the company that it is not planning to convene an advisory committee meeting to discuss the submission, according to Iovance.

The submission is based on clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. “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,” the company says. “TILVANCE-301 is expected to be well underway at the time of approval.”