The US FDA (Food and Drug Administration) has approved the first-ever chimeric antigen receptor (CAR) T-cell therapy, brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company) for adults with relapsed or refractory acute lymphoblastic leukemia (ALL). The approval of is based on results from a a multicenter, single-arm study, ZUMA-3, in which of 71 patients were studied. In the study, efficacy was drawn from the complete remission (CR) rate within 3 months after infusion and the duration of CR (DOCR). Results found that the average time to CR was 56 days.
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