Medical Minute: FDA Issues Strong Warning For New Cancer Therapy Treatment

A new therapy making strides in cancer treatment is now under review by the FDA.

In 2017, the FDA approved the first Car T-cell therapy.

Medical experts call it a "breakthrough" and "game-changer" when it comes to cancer treatment.

Now, it's under review after the FDA issued a strong warning.

“Immunotherapy has really come on as quite an advance in cancer care.”

Car T-cell therapy is a type of cellular immunotherapy used for patients with certain types of leukemias and lymphomas, as well as multiple myeloma.

It uses the patient's own immune system cells to attack cancer cells.

“The blood comes out. It goes through a machine that removes the T-cells that we are interested in and the blood is returned to the patient," a doctor said.

The T-cells are then sent to a lab to be engineered into Car T-cells. After a few weeks, they are returned to the patient's bloodstream where they can find and destroy the cancerous cells.

“We are actually taking the cells out and reprogramming them to get the strongest response possible from these chimeric antigen receptor T-cells, or CAR T-cells," the doctor said.

Studies show positive response rates with Car T-cell therapy, with many patients entering remission and survival rates increasing.

But now, the FDA is investigating reports of T-cell cancers in people who had the treatment, with outcomes including hospitalizations and death.

The FDA is instructing the manufacturers of these therapies to add boxed warnings, the highest safety-related warning.

It said patients and clinical trial participants should also be monitored for new cancers.

Despite the warning, the FDA said it has no concern about the continued use of this therapy, saying "the overall benefits of these products continue to outweigh their potential risks for their approved uses."