FDA requires Boxed Warning for risk of T-cell malignancies with approved CAR T-cell therapies.
The FDA has mandated that the boxed warning for all approved CAR T-cell therapies be updated to include the serious risk of T-cell malignancies
The agency is also requiring updates to other sections of the labels pertaining to warnings and precautions, post-marketing experience, and patient counseling information and medication guide.
The FDA indicated that patients and participants in clinical trials receiving CAR T-cell therapy should be monitored life-long for secondary malignancies. The FDA added that the manufacturers should be contacted if a new malignancy occurs after treatment with any of the products listed below as all currently approved BCMA-directed and CD19-directed CAR T-cell products carry a serious risk of T-cell malignancies.
Idecabtagene vicleucel (Abecma); Lisocabtagene maraleucel (Breyanzi); Ciltacabtagene autoleucel (Carvykti); Tisagenlecleucel (Kymriah); Brexucabtagene autoleucel (Tecartus); Axicabtagene ciloleucel (Yescarta).
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