Posted by Michael Wonder on 25 Aug 2022
Iovance Biotherapeutics initiates biologics license application submission for lifileucel in advanced melanoma
25 August 2022 - First TIL therapy BLA submission initiated with U.S. FDA.
Iovance Biotherapeutics today announced that it has initiated a rolling biologics license application submission to the US FDA for lifileucel, a tumour infiltrating lymphocyte (TIL) therapy, in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy.
