FDA approves revolutionary treatment against advanced melanoma

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

The treatment, called Amtagvi, from Iovance Biotherapeutics, is for patients with metastatic melanoma who have already tried other drugs that have not worked. It is known as TIL therapy and involves increasing the number of immune cells within tumors, harnessing their power to fight cancer.

This is the first time that a cell therapy has been approved to treat solid tumors. The drug received rapid approval based on the results of a Phase 2 clinical trial. 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 potential discounts and insurance coverage – is 515,000 per patient.

Dan Bennett, 59, believes the therapy has allowed him to survive the stage 4 melanoma he suffers from. Courtesy Dan Bennett

“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,” she says. “You run out of options quickly.”

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

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

TIL stands for tumor-infiltrating lymphocytes, which are immune cells that exist 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 the patient’s tumor and replicate them billions of times in a laboratoryand then reinfuse them again 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 a 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 modifications are needed), they just need an 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. TIL cells are first harvested from the tumor through a minimally invasive procedure and then grown and multiplied in the laboratory, a process that takes 22 days, according to Iovance.

While that happens, patients receive chemotherapy to eliminate their immune cells and make room for billions of new melanoma-fighting TIL cells. Once the TIL cells are reinfused into the body, patients receive a drug called interleukin-2 to further stimulate those cells.

Hwu said that most side effects in patients undergoing TIL therapy are not due to the reinfusion of cells, but rather due to chemotherapy and interleukin-2. These can include nausea and extreme fatigue, and patients are also vulnerable to other illnesses because the body is depleted of disease-fighting white blood cells.