Lifileucel (Amtagvi®): A Comprehensive Clinical and Regulatory Monograph on the First-in-Class Tumor-Infiltrating Lymphocyte (TIL) Therapy for Solid Tumors

I. Introduction and Drug Profile

1.1. Overview of Lifileucel as a Landmark Therapy

Lifileucel, marketed under the brand name Amtagvi®, represents a significant paradigm shift in the field of oncology. Its approval by the U.S. Food and Drug Administration (FDA) on February 16, 2024, established it as the first tumor-infiltrating lymphocyte (TIL) therapy and, more broadly, the first cellular therapy to receive regulatory clearance for the treatment of a solid tumor.[1] This milestone marks the clinical culmination of more than three decades of pioneering research into adoptive cell therapy (ACT), a field largely initiated by Dr. Steven Rosenberg and his colleagues at the National Cancer Institute (NCI).[4] Lifileucel is administered as a one-time, individualized T cell therapy, specifically developed to address the profound unmet medical need for patients with advanced melanoma who have exhausted standard treatment options.[5]