The US Food and Drug Administration (FDA) has approved obecabtagene autoleucel (obe-cel) in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Obe-cel, which is manufactured by Autolus, is CD19-directed genetically modified autologous T-cell immunotherapy.
Efficacy was based on data from the open-label, multicenter, single-arm FELIX trial. Enrolled patients were required to have relapsed following a remission lasting 12 months or less, relapsed or refractory ALL following two or more prior lines of systemic therapy, or disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation.
Of the 65 patients evaluable for efficacy, 27 patients (42%; 95% CI; 29%–54%) achieved CR within three months. The median duration of complete remission achieved within three months was 14.1 months (95% CI; 6.1–not reached), according to a press release from the FDA.
