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CAR-T Labels Take Different Approaches To Malignancy Safety Updates

 
• By Sue Sutter

US FDA has said that the risk of secondary malignancies is applicable to all currently approved BCMA- and CD19-directed genetically modified autologous CAR-T cell immunotherapies, but only one product label, J&J’s Carvykti, has added the safety issue to its existing boxed warning.

One different
One of the six CAR-T therapies has added the risk of secondary malignancies to its label's boxed warning. • Source: Shutterstock

Just weeks after a US Food and Drug Administration safety alert across the class of chimeric antigen receptor T-cell (CAR-T) therapies, differences in labeling related to the risk of secondary malignancies are emerging among the six approved products.

Johnson & Johnson and Legend Biotech Corp.’s Carvykti (ciltacabtagene autoleucel) was the first – and to date only – CAR-T product to add the risk of secondary malignancies to its existing boxed warning

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