The FDA has provided yet another twist in the Iovance Biotherapeutics saga. After years of delays, the biotech was on track to receive an approval decision on its tumor-infiltrating lymphocyte (TIL) melanoma therapy this year only for the FDA to delay the deadline because of “resource constraints.”
Iovance has suffered a series of setbacks over the past three years. At one point, the biotech planned to file for approval of lifileucel in 2020. That target slipped to 2021 when the FDA pushed back on potency assays and moved into 2022 as work to meet the agency’s demands dragged on. In the end, the company completed its submission this year, putting it on track to receive accelerated approval in late November.
Now, the FDA has pushed its decision date back to February 2024. Iovance attributed the three-month delay to constraints at the FDA, which reportedly had “insufficient resources to review a recent response to an information request” before a late-cycle review meeting that was scheduled for this week.
Iovance met with the FDA on Thursday, a few days later than planned. According to the biotech, the regulator acknowledged its resource constraints and agreed to work to expedite the remaining review. Expediting the review could enable the FDA to reach a decision before the new deadline in late February.
The biotech tried to allay the concerns of investors, stating that the FDA has completed inspections of clinical trial sites and manufacturing facilities, found no major review issues and has no plans to hold an advisory committee meeting. According to Iovance, the agency has expressed no concerns on the status of a confirmatory trial. The study will be “well underway” by the PDUFA date, Iovance said.
Shares in Iovance fell 14.5% over the course of Thursday but then rebounded 10% in premarket trading in the wake of the biotech’s statement after market close. They were trading at $5.10 ahead of the markets opening Friday.