Autolus Therapeutics plc is awaiting US Food and Drug Administration acceptance of the biologics license application (BLA) it submitted in November for the CD19-targeting chimeric antigen receptor T-cell (CAR-T) therapy obecabtagene autoleucel (obe-cel) in the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), an indication currently only held by one CAR-T, Gilead Sciences, Inc.’s Tecartus. In the meantime, the company continues to report data from the Phase Ib/II FELIX clinical trial showing strong efficacy and better safety than competing CAR-T therapies.
Autolus Shows Long Responses To CD19 CAR-T Therapy In Adult ALL Patients
Responses Longest With Low To Intermediate Tumor Burden
Autolus presented event-free survival rates and other updated results at ASH from its Phase Ib/II FELIX clinical trial of obe-cel, a CD19 CAR-T therapy recently submitted for US FDA approval.
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