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FDA Approves Gilead's Tecartus for Acute Lymphoblastic Leukemia

NEW YORK – The US Food and Drug Administration on Friday approved Gilead/Kite's CAR T-cell therapy brexucabtagene autoleucel (Tecartus) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval follows a supplemental biologics license application that Gilead submitted to the agency in April, which included data from the Phase I/II ZUMA-3 trial. After a year of follow-up in that trial, 65 percent of evaluable patients treated with the autologous CAR T-cell therapy achieved complete remission or complete remission with incomplete hematological recovery. The median duration of remission among efficacy evaluable patients was 13.6 months.

The treatment's toxicities were generally well-managed, according to Gilead, although 26 percent of patients experienced grade 3 or higher cytokine release syndrome, and 35 percent experienced grade 3 or higher neurological toxicities.

Brexucabtagene autoleucel involves harvesting patients' immune cells, engineering them to target CD19, then reinfusing them after the patient has undergone a lymphodepleting chemotherapy regimen. Last year, the FDA granted the autologous treatment accelerated approval for relapsed or refractory mantle cell lymphoma.

According to the drugmaker, brexucabtagene autoleucel's ALL indication is currently under regulatory review in the EU and UK as well.