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FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

November 30, 2023


Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies.

CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma.

T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).

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