AMTAGVI (Lifileucel)

Amtagvi (lifileucel) is an autologous TIL (tumor-infiltrating lymphocyte) therapy approved by the FDA in February 2024 for the treatment of unresectable or metastatic melanoma in adults who have failed anti–PD-1 immunotherapy and, if BRAF V600 positive, targeted therapy with BRAF ± MEK inhibitors. The approval is accelerated, and continued approval is contingent upon confirmatory evidence of clinical benefit. <a id="