Autolus Therapeutics announces acceptance of MAA by EMA for obe-cel

Autolus Therapeutics announces that the European Medicines Agency, EMA, has accepted the Company’s Marketing Authorization Application, MAA, for obecabtagene autoleucel, obe-cel. Obe-cel is Autolus’ lead investigational chimeric antigen receptor T cell therapy, for the treatment of patients with relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia. The MAA submission was based on data from the pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL. Autolus’ Nucleus site has recently received the formal certification from the MHRA following a full inspection of the site in February 2024. The MHRA issued two new GMP certificates to cover both clinical and commercial manufacture from the site. “Along with the recent acceptance of the BLA by the FDA, the acceptance of our EU marketing application is an important milestone in expanding into the European market and delivering this potentially transformative therapy to B-ALL patients,” commented Dr. Christian Itin, Chief Executive Officer of Autolus. “We look forward to working with the EMA throughout the evaluation process of obe-cel, and thank the internal team at Autolus for their work on the submission and Nucleus site inspection.”