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NEW YORK - The US 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 analyzed, 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.
The products in question include Bristol Myers Squibb's Breyanzi as well as 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 a 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 having been administered in the United States, the overall rate of T-cell cancers among people receiving CAR-T therapies appears to be quite low," the FDA officials wrote.
They said that as CAR-T technology is explored for uses beyond oncology, new strategies should be considered that might help reduce the risk of secondary cancers.
The FDA is aiming to raise awareness of the secondary cancer risk, Mamonkin said. "There are a lot of investigational therapies out there," he noted.
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