FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

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As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed…

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