FDA Requires Boxed Warning for Secondary Cancers on CAR-T Therapies | BioSpace

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Pictured: FDA signage at its headquarters in Maryland/iStock, hapabapa

The FDA announced on Thursday that it will officially require an update to the boxed warnings of CAR-T cell therapies, which should now also alert patients and prescribers to a heightened risk of developing secondary T cell malignancies.

All six commercially available CAR-T therapies will be affected, including Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel), Novartis’ Kymriah (tisagenlecleucel), as well as Gilead’s Tecartus (brexucabtagene autoleucel) and Yecarta (axicabtagene ciloleucel).

The FDA will also mandate amendments to other sections of their labels, including the warnings and precautions, postmarketing experience, patient counseling information and medication guide sections.

Patients and clinical trial participants being given these products should also be followed “life-long” for the potential development of secondary T cell cancers, according to the regulator’s announcement.

The FDA…
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