The European Commission has granted marketing authorization for Autolus Therapeutics’ CAR-T therapy, Aucatzyl, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL).
Aucatzyl, a CD19-directed genetically modified autologous T cell immunotherapy, was approved for the same indication by the U.S. FDA in November 2024 and authorized by UK’s MHRA in April 2025.
The EC approval — which applies to all 27 European Union Member States, Iceland, Norway and Liechtenstein — was based on the results of the FELIX study, which demonstrated a complete response rate of 76.6% and a 21.2-month median response duration.
Aucatzyl is designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR-T cell therapies. It achieves this by utilizing a fast target binding off-rate to minimize excessive activation of the programmed T cells. The therapy is administered as split dose infusion on day 1 and day 10 (±2 days) based on bone marrow blast assessment and preceded by fludarabine and cyclophosphamide lymphodepleting chemotherapy.
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