FDA Approves Cellular Therapy for Advanced Melanoma

Approval provides early access to therapy while clinical trials continue.

The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults with a form of skin cancer (melanoma) that cannot be surgically removed or has metastasized to other areas of the body. The approval, granted under the Accelerated Approval pathway for serious or life-threatening conditions, is for those previously treated with other therapies such as a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Director Peter Marks of the FDA’s Center for Biologics Evaluation and Research. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

As the Lord Leads, Pray with Us…

  • For FDA researchers as they review and assess clinical trial results and consider medications and therapies for approval.
  • For Commissioner Robert Califf to be discerning as he heads the Food and Drug Administration.
  • For wisdom for Dr. Marks as he oversees the Center for Biologics Evaluation and Research.

Sources: Food and Drug Administration


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