On the day that the US Food and Drug Administration (FDA) announced its approval of the first CAR T-cell-directed therapy, the regulator has stressed its awareness of the potentially life-threatening side effects of these advanced new treatments.
Novartis’ (NOV: V) Kymriah (tisagenlecleucel) became not only the FDA’s first approved CAR-T therapy, but also its first gene therapy, on Wednesday, with the treatment carrying a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events.
"Today's approval provides physicians with an important tool to help manage this potentially life-threatening side effect"
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