Further FDA delay for Iovance's lifileucel in advanced melanoma

US biotech Iovance Biotherapeutics (Nasdaq: IOVA) said on Friday that, although its ongoing rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for lifileucel is expected to be completed in the first quarter of 2023, the FDA recently raised new questions that might prolong the approval process, but not by much.

The firm’s shares closed down 14.8% at $6.32 following the announcement.

Iovance received recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel, its lead compound. Iovance will address these FDA comments promptly and will now complete its rolling BLA submission during the first quarter of 2023.