The FDA's decision represents a landmark approval of a tumor-derived cellular therapy in a solid tumor cancer.
Last week, the FDA granted accelerated approval to lifileucel (Amtagvi; Iovance Biotherapeutics) for the treatment of adults with unresectable or metastatic melanoma that has been previously treated with other therapies.1
Lifileucel, a tumor-infiltrating lymphocyte therapy, is the first and only cellular therapy to be approved for metastatic melanoma and the only individualized T-cell therapy approved for a solid tumor
“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a statement.1 “The approval of [lifileucel] represents the culmination of scientific and clinical research efforts leading to a novel T-cell immunotherapy for patients with limited treatment options.”
The accelerated approval is supported by data from the phase 2 C-144-01 trial (
Among those who responded to treatment, 56.5%, 47.8%, and 43.5% maintained responses without tumor progression at 6, 9, and 12 months, respectively. The full trial results were published in The Journal for ImmunoTherapy of Cancer in 2022.1,4
Lifileucel is a tumor-derived autologous T-cell therapy, and this approval marks the first for a tumor-derived T-cell immunotherapy. Tissue from a patient's tumor is surgically removed prior to treatment, T cells are separated from the tissue, and then they are manufactured and reinfused as a single dose.
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