FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer
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 20 reports since the approval of the first CAR-T therapies in 2017, including 15 from the FDA’s self-reporting adverse event system known as FAERS.
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