FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma

On February 16, the US Food and Drug Administration (FDA) granted accelerated approval to lifileucel, 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.

For more information read the FDA announcement and the Iovance Biotherapeutics, Inc. announcement. 

Posted 2/19/2024