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Three boxes of Breyanzi on a dark blue background — biotech coverage from STAT
The FDA is looking into adverse events involving a number of CAR-T therapies, including Breyanzi. Illustration: STAT; Source: Business Wire

The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer.

“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 a statement.

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The agency noted that it is investigating reports of T cell lymphoma, including cancer cells carrying the engineered T cells, in patients who received CAR-T therapy. Experts in the field, which has produced multiple approved products to treat blood cancer, expressed surprise and puzzlement at the announcement, saying that they had not previously seen data about the risk.

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