FDA Approves First Cellular Therapy for Treatment of Unresectable or Metastatic Melanoma

On February 16, 2024, the FDA approved Iovance’s AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma.  AMTAGVI is indicated to treat adult patients with unresectable or metastatic melanoma that have previously been treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.  AMTAGVI is made by removing a portion of the patient’s tumor tissue and separating the patient’s T cells from the tumor tissue.  The T cells are then further processed and returned to the same patient as a single dose for infusion.  Frederick Vogt, Ph.D., J.D., Interim CEO and President of Iovance stated, “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.”