The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after receiving BCMA- or CD19-directed autologous CAR-T cell therapies.
The FDA’s warning encompasses all related products currently on the market, including Bristol Myers Squibb’s (BMS; NYSE: BMY) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson’s (J&J; NYSE: JNJ) Carvykti (ciltacabtagene autoleucel), Novartis’s (SWX: NOVN) Kymriah (tisagenlecleucel), and Gilead’s (NASDAQ: GILD) Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).
The ISCT’s global group responded by noting that the reported incidence of T-cell malignancies is lower than that associated with conventional treatments. They emphasized that the available data is not sufficient to fully assess the risk of CAR-T therapies, while also highlighting that the benefits of these therapies currently outweigh the potential risks.- Flcube.com
