RE:CAR-T update April 19, 2024 - 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.
[ This warning of the risk of development of secondary T-cell malignancies further opens the door for the use of ONCY's pelareorep in combination with CAR-T therapy followed by a "boost" of pelareorep in the treatment of solid tumors - given Dr. Richrd Vile's pre-clinical work at the Mayo Clinic has demonstrated that this pelareorep/CAR-T combination + boost regimen is "curative", and by extension may preclude CAR-T secondary malignancies. ]
https://www.biospace.com/article/fda-requires-boxed-warning-for-secondary-cancers-on-car-t-therapies/