"FDA Pushes for 'Boxed Warning' on CAR-T Cancer Therapies"

The US FDA has requested a "boxed warning" to be added to the prescribing information for CAR-T cancer therapies, including those made by Gilead Sciences, Johnson & Johnson, Novartis, and others, due to reports of patients developing T-cell blood cancer after treatment. Novartis has agreed to update the prescribing information for its CAR-T cell therapy Kymriah, while Bristol Myers is evaluating next steps for its therapies. The FDA has identified adverse events and clinical trial reports describing T-cell malignancies and considers the risks applicable to all therapies in the category.