CAR-T Safety Probe Causes Alarm, But Is Unlikely To Upend Therapies
Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.
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CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.
US FDA has received a total of 19 reports of T-cell malignancy involving BCMA- or CD19-directed autologous CAR-T cell immunotherapies and is evaluating the need for regulatory action. Focus on lentiviral and retroviral vectors could extend to safety of other types of gene therapies.
Novartis pioneered CAR-Ts for leukemia and lymphoma, and inspired by pioneering physician Georg Schett, it also hopes to be first in the race to revolutionize autoimmune disease treatment with the therapies, and has unveiled the first clinical data for its candidate.