The Food and Drug Administration (FDA) announced Friday that it approved a ground breaking cellular therapy treatment for patients with advanced melanoma, and surgery has been unsuccessful.
Amtagvi, a type of T-cell therapy, involves boosting immune cells within tumor tissue to help the body fight off the cancer. During the treatment, the patient’s t-cells are separated from the tumor, artificially multiplied and then returned to them via infusion, the FDA said in a press release.
“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a press release. “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.”
Amtagvi was approved under an accelerated pathway — reserved for serious or life-threatening illnesses when other therapies don’t work — and will give patients the ability to access the treatment while it undergoes further testing. The therapy has already undergone two clinical trials and the company, Iovance Biotherapeutics, is expected to conduct third larger confirmatory trial, per the release.
“Melanoma is a life-threatening cancer that can cause devastating impacts to affected individuals, with a significant risk of metastasizing and spreading to other areas in the body,” Nicole Verdun, director of CBER’s Office of Therapeutic Products, said. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”
Melanoma is often caused by exposure to ultraviolet light — such as sunlight or indoor tanning. While they only represent 1 percent of skin cancers, according to the FDA, they account for a significant number of cancer deaths.
The American Cancer Society projected in a recent report that a record 2 million cancer cases would occur in 2024, with cases of those getting cancer over the age of 65 falling and cases of those getting cancer between the ages of 50 and 64 rising.
