FDA approves first cell therapy to treat aggressive forms of melanoma

By Juliana Kim

Published February 17, 2024 at 12:14 PM EST

Amtagvi is the first cell therapy for solid tumors approved by the FDA.

The Food and Drug Administration has approved a novel type of cancer therapy to treat aggressive forms of melanoma using immune system cells from a patient's tumor.

The treatment, called Amtagvi, was developed by Iovance Biotherapeutics, a biotech company based in San Carlos, Calif.

It is intended for patients whose melanoma cannot be removed with surgery or has spread to other parts of the body.

"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," Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said in a statement announcing the approval on Friday.

Melanoma develops when the skin cells that produce pigment start to grow out of control, according to the American Cancer Society. A major risk factor is exposure to ultraviolent light, which typically comes from the sun or tanning beds.

The tumor is easy to treat when detected early. But if it's not removed in time, melanoma can quickly spread to other parts of the body.

Amtagvi is designed to fight off advanced forms of melanoma by extracting and replicating T cells derived from a patient's tumor. T cells are part of the immune system. While they can typically help fight cancer, they tend to become dysfunctional inside tumors.

The newly approved medicine is similar to CAR-T, which is mainly used to treat blood cancers. Amtagvi is the first cell therapy approved by the FDA for solid tumors.

Amtagvi was fast-tracked through the FDA's accelerated approval pathway, a program to give patients with urgent, life-threatening illnesses early access to promising treatments.

Although Amtagvi was given the greenlight, Iovance Biotherapeutics said it is in the process of conducting an additional trial to confirm the treatment's efficacy, which is required by the FDA.

Melanoma only accounts for 1% of all skin cancer cases but it has been linked to a "significant number" of cancer-related deaths, according to the FDA.

The American Cancer Society estimates that in 2024, about 100,000 new cases of melanoma will be diagnosed and about 8,000 people will die from the skin cancer.