FDA approves revolutionary treatment against advanced melanoma

By Erica Edwards, Anne Thompson and Marina Kopf – nbcnews

The Food and Drug Administration (FDA) this Friday approved a new cancer therapy that could one day change the way the most aggressive and advanced tumors are treated.

Iowans BioTherapeutics’ treatment, called Amtagvi, is for patients with metastatic melanoma who have already tried other drugs that haven’t worked. This is known as TIL therapy and involves increasing the number of immune cells within the tumor, harnessing their power to fight cancer.

This is the first time that cell therapy has been approved to treat solid tumors. The drug received rapid approval based on the results of Phase 2 clinical trials. The company is conducting a larger Phase 3 trial to confirm the benefits of the treatment.

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The price of the therapy – before possible discounts and insurance coverage – is ₹515,000 per patient.

“This is going to be huge,” said Dr. Elizabeth Buchbunder, a senior physician at the Dana-Farber Cancer Institute in Boston. “Melanoma is not one of those cancers where there are about 20 different treatments,” he says. “You run out of options quickly.”

“This Friday’s approval is only for the treatment of melanoma, the deadliest cancer, but experts say it shows promise for treating other solid tumors, which account for 90% of all cancers.”

“Our hope is that future iterations of TIL therapy will help patients with lung cancer, colon cancer, head and neck cancer, bladder cancer and many other types of cancer,” said Dr. Patrick Hsu, CEO of Moffitt Cancer Center in Tampa, Florida. Will be important for.” , Moffitt has been involved in clinical trials of TIL therapy.

TIL stands for tumor-infiltrating lymphocytes, which are immune cells that are present within tumors. But there are not enough such cells to effectively fight cancer cells. TIL therapy involves, in part, Extract some of those immune cells from a patient’s tumor and replicate them billions of times in the labAnd then put them back into the patient.

It is similar to CAR-T cell therapy, in which healthy cells are removed from a person’s body and then modified in the laboratory to fight cancer. It is often used for difficult-to-treat blood cancers such as leukemia and lymphoma. With TIL therapy, the cells used are already programmed to recognize cancer (no laboratory modification required), they just need to increase in number to fight it.

Like CAR-T, TIL therapy is a one-time treatment, although the entire process can take up to eight weeks. According to Iovans, TIL cells are first extracted from the tumor through a minimally invasive procedure and then grown and multiplied in the laboratory, a process that takes 22 days.

While this happens, patients are given chemotherapy to destroy their immune cells and make room for billions of new TIL cells that fight the melanoma. Once the TIL cells reenter the body, patients are given a drug called interleukin-2 to further stimulate those cells.

Hvu said that most of the side effects in patients undergoing TIL therapy are not caused by the reanimation of the cells, but by the chemotherapy and interleukin-2. These can include nausea and extreme fatigue, and patients also become more vulnerable to other illnesses as the body decreases disease-fighting white blood cells.