NEW YORK – Iovance Biotherapeutics said on Friday that, based on feedback from the US Food and Drug Administration, it now expects to complete the regulatory filing for its autologous tumor-infiltrating lymphocyte (TIL) therapy lifileucel during the first quarter of 2023.
The announcement marks the latest in a series of recurring delays the firm has faced since 2019, when it first announced plans to file approval for lifileucel as a treatment for advanced melanoma patients.
According to Iovance, in the most recent FDA feedback is related to an amendment to the ongoing investigational new drug application it submitted during the third quarter of this year. The agency has requested "supplemental assay validation information and comparability data for lifileucel."
On a conference call to discuss the update with investors on Friday, Iovance Interim CEO Fred Vogt explained that the request for additional validation has to do with the firm's lifileucel potency assay — which is actually a series of assays collectively dubbed a potency matrix — and that the comparability data has to do with ensuring the treatment's comparability when it's manufactured at different physical sites.
"This is part of good manufacturing practice … that you [validate] that the assays perform accurately and linearly and reproducibly across different conditions," Vogt said. "It's not a change to the assay."
Iovance has been submitting pieces of its biologics license application for lifileucel on a rolling basis since August, and although Vogt expressed confidence that the firm is "close to completion" of the full rolling BLA submission, he also recognized that there isn't precedent for the regulatory process since lifileucel is a first-in-class therapy.
"There's some details in what FDA gave us which has never been seen before and is new to the space… so we're learning some things as they learn some things," Vogt said. "We think it's really just supplementary validation driving the whole thing, and we can do that fairly quickly."