Autolus Therapeutics (NASDAQ: AUTL) has announced that the European Commission (EC) has granted marketing authorization for AUCATZYL for the treatment of adult patients aged 26 and over with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
According to Autolus, the approval was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The results were published in the New England Journal of Medicine in November 2024.
In a statement, Dr. Christian Itin, CEO of Autolus, commented, “We believe AUCATZYL represents an important new treatment option for physicians treating adult r/r B-ALL patients. With the EU marketing authorization, we are now evaluating market entry opportunities in EU countries.”
