FDA Delays the Review of Iovance’s BLA Treatment of Advanced Melanoma
15 September 2023
Iovance’s BLA sought accelerated approval of lifileucel for patients with advanced melanoma after demonstrating positive data from the C-144-01 clinical trial. The accelerated approval aimed to assess the randomized Phase III TILVANCE-301 trial to serve as a confirmatory study to support full approval. However, the FDA has notified Iovance of resource constraints, delaying the review of Iovance’s Biological License Application (BLA).
Biotechnology company, Iovance Biotherapeutics has announced that the FDA has required additional time to complete the Priority Review of Iovance’s BLA for lifileucel due to resource constraints. The extension for the new target action date of February 24, 2024, was applied under the Prescription Drug User Fee ACT (PDUFA) however, the FDA will be working closely with Iovance to expedite the remaining review for a potentially earlier approval date.
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, where applicable. There are currently no FDA-approved therapies in this treatment setting. If approved, lifileucel will be the first and only TIL therapy for patients with advanced melanoma as well as the first one-time therapy for a solid tumor cancer.
Interim President and CEO of Iovance, Fredrick Vogt, PhD, J.D., stated:
“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 U.S. melanoma community immediately following an approval.”
In May 2023, the FDA accepted the BLA for lifileucel un the Priority Review with a previous grant of a Regenerative Medicine Advanced Therapy designation for lifileucel in advanced melanoma. However, prior to the planned late-cycle review meeting that was scheduled for September 11, 2023, Iovance had requested an information update for the ongoing BLA Review to which the FDA notified Iovance of its inadequate resources.
In a meeting with the FDA held on September 14, 2023, the FDA acknowledged the resource constraints and agreed to work closely with Iovance to expedite the remaining review. The FDA clarified that there are no major review issues and no plans to hold an advisory committee meeting.
“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,” Vogt added.
The FDA has also expressed no concerns about the status of the TILVANCE-301 confirmatory trial in frontline advanced melanoma, which remains on track to be well underway by the PDUFA date.
“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,” said Vogt.
The Priority Review status and the RMAT designation are not impacted by the date extension of the PDUFA.