Iovance Biotherapeutics (NASDAQ:IOVA) stock looked to soar at Friday’s market open, recovering from a steep loss on Thursday after the company said the US Foood and Drug Administration (FDA) needed more time to complete the priority review of its Biologics License Application (BLA) for its lifileucel melanoma therapy due to resource constraints.
In a statement, the company said 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.
Ahead of the opening bell, its shares were up 19.3% at $5.54. They declined 14.5% on Thursday.
Iovance said the overall BLA process for lifileucel 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, it said all pre-approval inspections of clinical sites, internal and external manufacturing, and testing facilities have been successfully completed.
Further, it said the FDA has no concerns about the status of the lifileucel Phase 3 TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date.
“While the resource constraints at FDA have extended our PDUFA date, Iovance and FDA remain engaged to complete the review process as quickly as possible,” commented Iovance interim president and CEO Dr Frederick Vogt.
“We appreciate FDA management’s efforts to expedite the remaining review so that we can bring lifileucel to critically ill patients with no other FDA-approved options after current standard of care.”
If approved, Iovance said Lifileucel will be the first and only tumor infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma, as well as the first one-time cell therapy for solid tumor cancer.
Lifileucel is an individualized therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. There are no FDA-approved therapies in this treatment setting.
Contact the author at stephen.gunnion@proactiveinvestors.com