Iovance says FDA updates PDUFA action date for lifileucel

Iovance Biotherapeutics announced the U.S. Food and Drug Administration, because of resource constraints, requires additional time to complete the Priority Review of Iovance’s Biologics License Application for lifileucel. 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 to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date. The FDA recently notified Iovance that they 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 meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review. 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.