Further details on FDA black box warning for CAR-T cell therapies
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies.
A recent article, published in the New England Journal of Medicine, says that the warning comes after the agency received reports of T cell malignancies in people who had been treated with this class of therapy.
The malignancies affected people who had been given BCMA-directed as well as CD19-targeting immuno-oncology products.
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