FDA updates PDUFA action date for lifileucel for the treatment of advanced melanoma

The BLA is seeking accelerated approval of lifileucel for patients with advanced melanoma. The FDA extended the new target action date for a decision under the Prescription Drug User Fee Act (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.

The overall BLA process continues under Priority Review with several recent positive status updates. The FDA reiterated there are no major review issues, and there are no plans to hold an advisory committee meeting. In addition, all pre-approval inspections of clinical sites. internal and external manufacturing and testing facilities have been successfully completed. 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 ( tumor infiltrating lymphocyte ) 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.