The U.S. Food and Drug Administration (FDA) granted accelerated approval to Iovance Biotherapeutics’ T-cell therapy treatment for unresectable or metastatic melanoma.
Iovance’s Amtagvi (lifileucel) is a one-time individualized tumor-infiltrating lymphocyte therapy; it is the first T-cell therapy for solid tumors to reach the market. On February 16, the FDA approved Amtagvi for adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 inhibitor, as well as a BRAF inhibitor with or without an MEK inhibitor if the tumor carries the BRAF V600 mutation.
While Amtagvi’s safety and efficacy have been evaluated in a multicenter trial prior to the FDA’s approval, the San Carlos, CA-based Iovance said in a statement that it is currently conducting an additional trial as required by the FDA.
Additionally, WuXi Advanced Therapies announced on February 21 that it has been given approval by the FDA to begin the analytical testing and manufacturing of Amtagvi for Iovance at its Philadelphia site.
