Iovance to Address FDA Requests for BLA of Lifileucel in Advanced Melanoma
Source: Onc Live, November 2022
After receiving recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel (LN-44) in the treatment of advanced melanoma, Iovance Biotherapeutics will address these comments and plans to complete its rolling biologics license application (BLA) submission during the first quarter of 2023.
In August 2022, the company submitted a rolling BLA to the FDA seeking the approval of lifileucel for the treatment of patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy.
“We continue to make substantial progress with our ongoing BLA submission and remain close to the finish line. The FDA has provided recent valuable feedback to the investigational new drug application and remains supportive during the rolling BLA submission process,” Frederick Vogt, PhD, JD, interim president and chief executive officer of Iovance, stated in a press release. “Iovance is fully committed to securing FDA approval as soon as possible to deliver the first individualized, one-time cell therapy for advanced melanoma patients, who have a significant unmet medical need.”