Lifileucel Approval Paves the Way for Personalized Minimally-Invasive T-Cell Therapies
Source: Pharmacy Times, February 2025
The FDA’s accelerated approval of lifileucel (Amtagvi; Iovance Biotherapeutics) marks a major milestone in immunotherapy for metastatic melanoma, building on decades of research in tumor-infiltrating lymphocyte therapy.
On February 16, 2024, a significant milestone was reached in immunotherapy with the FDA’s accelerated approval of lifileucel (Amtagvi; Iovance Biotherapeutics), which is a tumor-derived autologous T-cell product for patients with unresectable or metastatic melanoma. This milestone follows over 35 years of academic research led by Steven A. Rosenberg, MD, PhD, and his team at the National Cancer Institute (NCI), as well as contributions from numerous clinical cancer centers, explained Alena Gros, MD, an investigator at the Vall d’Hebron Institute of Oncology in Barcelona, Spain, during a presentation at the 2025 inaugural American Association of Cancer Research Immunotherapy (AACR IO) Conference.
In the study that led to the accelerated approval of lifileucel, Rosenberg and his team evaluated the safety and efficacy of the drug in patients who had previously received systemic therapy, including a PD-1 inhibitor and, if BRAF V600 mutation-positive, a BRAF ± MEK inhibitor. Of 89 patients, 7 were excluded due to product specification or comparability issues. Patients underwent a lymphodepleting regimen before receiving lifileucel, followed by IL-2 (aldesleukin) to support cell expansion.