The Food and Drug Administration is investigating the risks of CAR-T cell immunotherapies, which are used to treat certain forms of cancers like lymphoma and leukemia.
The FDA says it has received reports of people getting T-cell malignancies, a type of cancer that originates in the white blood cells that are involved in a person's immune system.
CAR-T therapies are approved under several products: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta. The FDA says the T-cell malignancies have occurred in patients who have been treated with several of the approved products.
"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 FDA said in a statement.
Federal health officials say patients receiving the treatments should be monitored for new malignancies. Clinicians are asked to report new malignancies to drug's manufacturer. They should also obtain instructions on collection of the patient's samples for further testing, the FDA says.
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