The FDA is reviewing the safety of CAR-T therapies after reports of patients who developed blood cancers following treatment with the products, an inquiry that’s almost certain to raise questions about the class as its developers seek to expand its use.
The agency told Endpoints News that it has received 19 reports since the approval of the first CAR-T therapies in 2017, including 14 from the FDA’s self-reporting adverse event system known as FAERS.
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