One of the initial reactions to news that the US Food and Drug Administration is investing reports of T-cell malignancies in patients treated with approved CD19- and BCMA-targeting chimeric antigen receptor T-cell (CAR-T) therapies for hematological malignancies was that CAR-T candidates being developed for autoimmune diseases could be derailed by the potential safety risk. However, many patients with autoimmune diseases and cancer already accept some risk of secondary malignancy.
Key Takeaways
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The FDA’s investigation of T-cell malignancies associated with CAR-T products approved for blood cancers may impact the use of CAR-T therapies in autoimmune diseases.
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Secondary malignancies are a known risk with many drugs, including treatments for cancer as well as for autoimmune diseases. T-cell malignancies are not a common secondary malignancy, however
Several well-known drugs for inflammatory diseases come with boxed warnings about potential cancer risks, including Humira (adalimumab) with a warning about lymphoma and other malignancies in children, adolescents and young adults treated with the AbbVie Inc. product and other anti-TNF biologics. Pfizer Inc
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