FDA extends PDUFA date for Iovance's lifileucel BLA to Feb 24, 2024 due to resource constraints

IOVANCE BIOTHERAPEUTICS, INC.

FDA extended PDUFA target action date for lifileucel BLA from prior to February 24, 2024, citing resource constraints.
No major review issues; all pre-approval inspections of clinical sites and manufacturing facilities completed successfully.
No advisory committee meeting planned; Priority Review and RMAT designation remain intact.
FDA agreed to work with Iovance to expedite remaining review, potentially allowing earlier approval.
Lifileucel seeks accelerated approval for advanced melanoma with no currently FDA approved therapies in that setting.

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