Brexucabtagene autoleucel & B-cell acute lymphoblastic leukemia (B-ALL)

FDA status

In October 2021, the US Food and Drug Administration (FDA) granted approval for brexucabtagene autoleucel specifically for adult patients suffering from relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). This decision was informed by the results of the ZUMA-3 trial, a single-arm, multicenter study identified by the code NCT02614066. The trial demonstrated significant and lasting response rates among adults who had undergone extensive prior treatments. Brexucabtagene autoleucel is intended for use in patients aged 18 and older who have relapsed or refractory B-cell precursor AL…