FDA warns about CAR-T therapy and its possible consequences

The U.S. Food and Drug Administration (FDA) has investigated 22 cases of T-cell cancers that occurred after CAR-T treatment, two senior FDA officials said, days after asking drugmakers to add a serious warning on the label of its cancer therapies that use CAR-T technology.

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


Experts said three cases in which genetic sequencing was performed showed evidence that the CAR-T product was likely involved in the development of the cancer.

“We’re not sure how many cases have been analyzed, but three out of 22 seems like a really low incidence,” said Max Mamonkin, associate professor at the Center for Cellular and Gene Therapy at Baylor College of Medicine.


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

CAR-T treatment, which the FDA says has been used in 27,000 people in the United States, generally involves taking 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.


The products in question include Breyanzi from Bristol Myers Squibb and Abecma, which BMS developed with 2seventy bio. J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG’s Kymriah and Gilead’s Tecartus and Yescarta are also part of the investigation.

Marks and Verdun said the FDA has enough data on about 14 of the cancer cases to determine that those cancers had manifested within two years of treatment.


Still, “with more than 27,000 doses of the six approved products that have been administered in the United States, the overall rate of T-cell cancers among people receiving CAR-T therapies appears to be quite low,” officials wrote. the FDA.

They said that as CAR-T technology is explored for uses beyond oncology, new strategies that could help reduce the risk of secondary cancers should be considered.


The FDA aims to raise awareness about the risk of secondary cancer, Mamonkin said. “There are many therapies under investigation,” she noted.

(With information from Reuters)