US FDA examines 22 cases of cancers in CAR-T probe

Jan 25,2024

New York: The U.S. Food and Drug Administration has been looking into 22 cases of T-cell cancers that occurred after treatment with CAR-T, two top FDA officials said on Wednesday, days after asking drugmakers to add a serious warning on the label of their cancer therapies that use the CAR-T technology.

In an article published in the New England Journal of Medicine, the officials - Dr Peter Marks and Dr Nicole Verdun - said that secondary malignancies have been reported in conjunction with five of the six available CAR-T products and that the cancers included T-cell lymphoma, T-cell large granular lymphocytosis, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma.

 They said that three cases for which genetic sequencing was done showed evidence that the CAR-T product was most likely involved in development of the cancer.

"We are not sure how many cases have been analysed, but three out of 22 seems like a really low incidence," said Max Mamonkin, associate professor at Baylor College of Medicine's Center for Cell and Gene Therapy.

He said the risk of secondary cancers is higher with standard chemotherapy, which many patients probably received before being referred for CAR-T.

CAR-T treatment, which the FDA said has been used for 27,000 individuals in the United States, generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.

Source: Healthworld