CAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology
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.
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More than 100 biopharma executives and experts told Scrip their predictions for therapeutic area advances in the coming year. The recent commercial success of GLP-1s in diabetes and obesity and their potential in further disease areas fuelled excitement around the metabolic space. Expectations were also positive in neurology following the launch of Leqembi for Alzheimer’s disease in 2023, while the multiple opportunities to improve cancer treatment kept oncology top of the pile overall.
Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.
Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.