FDA delays review of Iovance melanoma BLA

Sept. 15, 2023

The FDA has postponed its target action date for the accelerated review of Iovance Biotherapeutics' advanced melanoma drug, lifileucel, citing resource constraints.

Lifileucel has the potential to become the first individualized, one-time tumor-infiltrating lymphocyte therapy for patients with advanced melanoma. Its BLA was accepted back in May and granted priority review. 

Initially given a target action date of November 25, now the FDA has said that it needs more time, citing insufficient resources to review a response to an information request for the BLA review ahead of its review meeting that was initially scheduled for September 11. The new PDUFA date is now February 24, 2024 but according to Iovance, the agency has agreed to collaborate to expedite the remaining review process. 

Despite being hit with a few delays through its regulatory journey, the agency has said its not planning on holding an advisory committee meeting and that there are no major review issues. The FDA has also successfully inspected all internal and external manufacturing facilities.