1. Pink Sheet

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.

The Center for Biologics Evaluation and Research mandated a new boxed warning for six CAR-T therapies acknowledging the risk of...

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