Following CAR-T safety label changes, FDA officials share new details about secondary cancer cases
More than half of the cancer cases the FDA is examining as part of its CAR-T safety investigation occurred within two years of treatment, according to an editorial penned by top FDA officials and published Wednesday.
The FDA is investigating 22 cases of T cell cancers developing after patients underwent CAR-T cell therapy treatment, the FDA’s Nicole Verdun and Peter Marks wrote in the New England Journal of Medicine. The editorial echoes some of the information previously shared by Marks, who oversees the regulation of cell and gene therapies at the FDA, at an event earlier this month.
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