On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously treated with other therapies (a programmed cell death protein 1-blocking antibody and, if BRAF V600-mutation positive, a BRAF inhibitor with or without a mitogen-activated protein kinase inhibitor).
Amtagvi is a tumor-derived autologous T-cell immunotherapy comprising a patient’s own T cells. It was approved through the accelerated approval pathway.
