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In April, the FDA warned of risk of secondary cancers in people receiving CAR-T cell therapy. A large study now finds the risk is low and not related to the CAR-T cells.
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated ...
Less manufacturing time could be the difference between a patient receiving this life-saving therapy vs not.
CAR T cells directed against the B-cell maturation antigen (BCMA) are linked to systemic and neurological side effects, while the antibody teclistamab is associated with increased infection risk.