FDA extends PDUFA date for lifileucel due to resource constraints

Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ (Nasdaq: IOVA) Biologics License Application (BLA) 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 (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date, the US late-stage biotech said.

Iovance shares closed up 13.5% on Friday and gained a further 5.5% to $5.56 in pre-market trading today.