Inside Precision Medicine February 21, 2024
The Food and Drug Administration (FDA) has granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma. It is the first, and the only one-time, T cell therapy to receive FDA approval for a solid tumor cancer. The application was granted Priority Review, Fast Track designation, Regenerative Medicine Advanced Therapy designation, and Orphan Drug designation.
“The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), in a release.
An estimated 8,000 people in the...
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