Reaction: FDA launches investigation into possible increased risk of developing certain tumours with CAR-T therapies
The US Food and Drug Administration (FDA) has issued a statement reporting that it has received reports of T-cell tumours in patients who received various CAR-T cell treatments. As quoted in the statement, "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".