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CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions

 
• By Derrick Gingery

Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.

CAR T cell and cancer
Sponsors have 30 days to submit updated labeling or a rebuttal explaining why the changes is not needed. • Source: Shutterstock

Any questions about updating CAR-T labels to include the risk of secondary malignancy have been answered by the US Food and Drug Administration, although sponsors still are not certain the products cause the adverse event.

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