FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma
Source: Onc Live, September 2023
The FDA has extended the priority review period for the biologics license application (BLA) seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.
The regulatory agency needs additional time due to resource constraints, according to an announcement from Iovance Biotherapeutics. The FDA told Iovance that the agency had insufficient resources to review a recent response to an information request for the ongoing BLA review prior to the planned late-cycle review meeting scheduled for September 11, 2023. In a subsequent meeting on September 14, 2023, the FDA pointed to resource constraints and agreed to work closely with Iovance to expedite the remaining review.
After receiving an initial target action date of November 25, 2023, under the Prescription Drug User Fee Act (PDUFA), the updated PDUFA date is February 24, 2024.