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

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