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FEBRUARY 20, 2024

Amtagvi Granted Accelerated Approval for Unresectable or Metastatic Melanoma


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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,