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Autolus Therapeutics plc (AUTL) said the FDA has accepted its Biologics License Application or BLA for obecabtagene autoleucel or obe-cel for patients with relapsed/refractory Adult B-Cell Acute Lymphoblastic Leukemia.
Claire Roddie, MD, PhD, presents data from the pooled analysis of the ongoing FELIX phase Ib/II study investigating obecabtagene autoleucel in patients with relapsed/refractory adult B-cell acute lymphoblastic leukemia.
Obecabtagene autoleucel elicited durable responses in patients with relapsed or refractory B-cell acute lymphoblastic leukemia independent of leukemic burden at lymphodepletion, although better outcomes were observed in those with lower burden.
Claire Roddie, MD, discusses the rationale for investigating obecabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, details the key topline findings from the FELIX trial, and provides insights on unmet needs that remain for this patient population.
Obecatagene autoleucel was associated with a 76% complete response (CR)/CR with incomplete count recovery rate in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.