WASHINGTON (dpa-AFX) - The Chimeric Antigen Receptor T-cell (CAR-T) therapy, a treatment offering hope to patients with certain types of cancers, has recently raised concerns due to reports of secondary cancer following the treatment.
In light of these reports, the FDA is now requiring label updates with black box warnings, which is the most serious safety alert on a medication's label, for all six commercial CAR-T therapies, including Bristol's Abecma and Breyanzi, Kite's Yescarta and Tecartus, J&J's Legend Biotech-partnered Carvykti, and Novartis' Kymriah, to include T-cell malignancies in the boxed warning section of each product's label.
The FDA wants the companies to include a paragraph in those boxed warnings on the label to say, 'T-cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including,' followed by the product's name.
The FDA has given these companies a 30-day deadline to address its request and submit a supplement that includes the changes verbatim or a rebuttal statement outlining their objections. Failure to comply could result in potential enforcement action, such as fines and mandatory label adjustments.
Despite these developments, the FDA has stressed that the risk-benefit profiles of these products continue to be favorable for their current uses. While the companies have committed to updating or reviewing their labels in line with FDA guidance, they have also stated that they have not found a direct link between their products and T-cell cancers.
Additionally, in a recent commentary published in Nature Medicine, several experts in cell therapy highlighted that the observed rate of T-cell malignancies is significantly lower than that associated with some other treatments.
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