Authored by Naveen Athrappully via The Epoch Times,
A gene therapy treatment used in cancer patients is under scrutiny by the U.S. Food and Drug Administration (FDA) after the agency received reports of new blood cancers among treated individuals.
The treatment, CAR-T, was first approved by the FDA in 2017 and is used in the treatment of blood cancers. However, the agency has received “reports of T-cell malignancies”—a group of blood disorders—among some of the patients who received CAR-T treatments, according to a Nov. 28 announcement.
The reported malignancies include lymphoma, a cancer of the lymphatic system which includes lymph nodes, the thymus gland, bone marrow, and the spleen.
“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said.
In CAR-T treatments, a type of white blood cells called T cells are removed from the blood of a patient. These cells are then genetically engineered to make proteins called chimeric…
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