Amtagvi Granted Accelerated Approval for Unresectable or Metastatic Melanoma

The FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

Safety and efficacy were evaluated in a global, multicenter, multicohort, open-label, single-arm trial in patients with unresectable or metastatic melanoma who had previously