FDA acceptance of the BLA of lifileucel for the treatment of advanced melanoma

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). The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues.

Lifileucel is a TIL therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. Under the FDA’s guidance, Priority Review allows for an six-month review from the time of BLA acceptance for treatments that, if approved, are substantially safer or more effective than standard of care therapies. The FDA also previously granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma.