Autolus Therapeutics plc announced 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 (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL).

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. Obe-cel has been granted Orphan Drug Designation by the FDA, Orphan Medical Product Designation by the EMA, Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and PRIority MEdicines (PRIME) designation by the EMA for adult r/r B-ALL.