The Food and Drug Administration announced on Friday that it had approved the use of a new cancer therapy that researchers say is a groundbreaking way to treat a majority of aggressive and advanced melanoma tumors.
The treatment, called Amtagvi, from Iovance Biotherapeutics, is aimed at people with metastatic melanoma who have already tried other drugs but have not had good results.
The drug uses TIL therapy which involves boosting the number of immune cells inside tumors to fight the cancer.
TIL therapy is a type of treatment in which tumor-infiltrating lymphocytes (a type of immune cell that can recognize and kill cancer cells) are removed from a patient’s tumor and grown in large numbers in a laboratory, according to the National Cancer Institute.
The lymphocytes are then given back to the patient by infusion to help the immune system kill the cancer cells.
According to the agency, it’s the first time TIL therapy has been approved to treat solid tumors.
The @US_FDA has granted accelerated approval for our therapy for advanced melanoma.
— Iovance Biotherapeutics (@IovanceBio) February 16, 2024
Learn more: https://t.co/02ZyLG8HPi
The company is conducting a phase 3 trial to confirm the treatment’s effect against the deadliest form of skin cancer.
The cost of the treatment, before insurance or other possible discounts, is $515,000 per patient, NBC News is reporting.
“This is going to be huge,” said Dr. Elizabeth Buchbinder, a senior physician at Dana-Farber Cancer Institute in Boston, told NBC News. Melanoma is “not one of those cancers where there’s like 20 different” possible treatments, she said. “You start running out of options fast.”
Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight or indoor tanning, the FDA explained. Although melanomas only represent approximately 1% of all skin cancers, they account for a significant number of cancer-related deaths, the FDA said. Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
Amtagvi is a tumor-derived autologous T cell immunotherapy, the FDA explained, meaning it is composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer.
The treatment begins when a portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patient’s T cells are separated from the tumor tissue, further manufactured and then returned to the same patient as a single dose for infusion.
While the treatment was developed for melanomas, researchers say it may hold promise for treatment of other solid tumors.
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