FDA Approves 1st T-Cell Therapy for Melanoma
Melanoma cancer patients with solid tumors can turn to a new treatment thanks to the U.S. Food and Drug Administration’s (FDA) approval of a new class of immunotherapy. The new treatment may offer hope to those facing an otherwise deadly stage of disease.
Amtagvi (lifileucel) is the first tumor-infiltrating lymphocyte (TIL) therapy to hit the market. The FDA granted accelerated approval to manufacturer Iovance Biotherapeutics on Friday for the drug’s use to treat patients with advanced melanoma that is unable to be removed with surgery, or that has spread to other parts of the body.
“The approval of AMTAGVI offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” said Samantha R. Guild, president of the AIM at Melanoma Foundation, in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”
“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in an agency 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 Utilizes Patient’s T-Cells to Fight Cancer
Melanoma is a type of skin cancer that starts in the cells that give skin its color, melanocytes. It often begins in the skin that is regularly exposed to sunlight, such as the arms, backs, face, and legs. While the exact causes aren’t clear, most research points to ultraviolet light exposure as a primary factor.
While it starts with the skin, the cancer can spread to the lymph nodes and other parts of the body. According to the American Cancer Society, about one in 33 white people will develop it, while one in 1,000 black people and one in 200 Hispanic people will.
The treatment is suitable for patients who have tried other forms of therapy, such as PD-1 blocking inhibitors or drugs that target the BRAF gene. PD-1 blocking inhibitors use antibodies to target specific proteins in the body to help the immune system fight off cancer cells. Drugs that target the BRAF gene help manage the growth and function of particular cells associated with skin cancer. According to the FDA, these therapies have some success with melanoma patients, but for those whose cancers have progressed, there has been a “high unmet medical need” until the approval of Amtagvi.
Amtagvi uses a patient’s T-cells, a cancer-fighting immune cell. To create the therapy, a portion of the patient’s cancer tumor is removed during surgery. The T-cells are separated from the tumor and returned to the patient during a single infusion. While other immunotherapies exist, this is the first FDA-approved, tumor-derived T-cell immunotherapy.
“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,” Dr. Nicole Verdun, director of the Office of Therapeutic Products in CBER, said in the press statement released Friday. “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 after a clinical study of 73 patients reviewed its safety and efficacy profile. According to the FDA, among those treated with the new medication, 31.5 percent of participants saw their tumors shrink. The therapy does come with side effects, including prolonged severe low blood count, severe infection, cardiac disorder, and the potential for developing worsened respiratory or kidney function. The therapy comes with a boxed warning about these risks, the FDA noted. Other common reactions included chills, fever, fatigue, fast heart rate, diarrhea, swelling, rash, low blood pressure, hair loss, infection, low oxygen levels, and shortness of breath.
