The FDA has introduced a new twist in the ongoing Iovance Biotherapeutics saga, causing further delays in the approval process for its tumor-infiltrating lymphocyte (TIL) melanoma therapy. The biotech company, which has faced numerous setbacks over the past three years, was anticipating an approval decision this year. However, the FDA has postponed the deadline due to “resource constraints.”
Iovance’s journey has been marked by challenges, with initial plans to seek approval for lifileucel in 2020. Delays ensued as the FDA raised concerns about potency assays, extending the timeline to 2021 and eventually into 2022 as efforts to meet the agency’s requirements continued. Finally, the company submitted its application this year, positioning itself for potential accelerated approval in late November.
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. Iovance attributes this three-month delay to resource limitations at the FDA, which reportedly struggled to review a recent response to an information request before a late-cycle review meeting scheduled for this week.
Despite the setback, Iovance recently held a meeting with the FDA, albeit slightly later than planned. According to the biotech company, the FDA acknowledged its resource constraints and committed to expediting the remaining review process. This effort could potentially lead to a decision before the extended deadline in late February.
“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. 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. We are confident in the potential for lifileucel to redefine the treatment paradigm for these patients. With the strength of our clinical data, manufacturing capabilities, and commercial readiness efforts, Iovance is well positioned to rapidly serve the US melanoma community immediately following an approval.”
– Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance
Iovance sought to reassure investors by highlighting that the FDA had completed inspections of clinical trial sites and manufacturing facilities, finding no significant review issues. Moreover, the agency has no plans to convene an advisory committee meeting and has expressed no concerns about the status of a confirmatory trial, which is expected to be “well underway” by the Prescription PDUFA date.
Despite a 14.5% decline in Iovance’s shares on Thursday, there was a 10% rebound in premarket trading following the biotech’s statement after the market’s close. As trading resumed on Friday, shares were valued at $5.10.