FDA Investigating ‘Serious Risk’ of New Cancers Arising From Gene Therapy Cancer Treatments

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....