1. Pink Sheet

US FDA Acknowledges Patient Frustration With CAR-T Boxed Warning

 
• By Sarah Karlin-Smith

An FDA question to a patient concerned about the negative impacts of the CAR-T boxed label warning during a recent listening session indicates the agency may be thinking about improving its dissemination of the information. 

stesthecope wrapped around sign that says "side effects"
A patient suggested the risks of CAR-T be put in context of the risks of other treatments. • Source: Shutterstock

A patient’s concern about the potentially unintended impacts of the boxed warning for CAR-T treatment may suggest a broader US Food and Drug Administration interest in revising the warning and being more thoughtful about presenting the information.

Key Takeaways

  • An FDA staff member focused on a patient’s concerns about the negative consequences of the CAR-T boxed warning on secondary malignancies at a recent CBER listening session, hinting the agency may be considering “optimizing” the label.

In January, the Center for Biologics Evaluation and Research mandated a new boxed warning for six CAR-T therapies acknowledging the...

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