FDA approves the first cellular therapy to treat unresectable or metastatic melanoma

SILVER SPRING, Md. — The U.S. Food and Drug Administration recently approved Amtagvi, 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 or has spread to other parts of the body that previously has been treated with other therapies.

“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.

“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,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”

Amtagvi was approved through the Accelerated Approval pathway, under which the FDA may approve drugs for serious or life-threatening illnesses or conditions where there is an unmet medical need.

A confirmatory trial is ongoing to verify Amtagvi’s clinical benefit.

The FDA granted the approval of Amtagvi to Iovance Biotherapeutics Inc.