Autolus Therapeutics (AUTL) announces that the European Commission, EC, has granted marketing authorization for AUCATZYL for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, r/r B-ALL. The EC 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 leukaemia. The results were published in the New England Journal of Medicine in November 2024. “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,” said Dr. Christian Itin, Chief Executive Officer of Autolus.
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