FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
Source: U.S. FOOD & DRUG ADMINISTRATION, February 2024
Today, the U.S. Food and Drug Administration approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (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 Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “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.”
Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight or indoor tanning. Although melanomas only represent approximately 1% of all skin cancers, they account for a significant number of cancer-related deaths. Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.