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Autolus Therapeutics Says Leukemia Drug Aucatzyl Gets EU Marketing Approval
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Autolus Therapeutics Says Leukemia Drug Aucatzyl Gets EU Marketing Approval
Jul 21, 2025 4:59 AM

07:42 AM EDT, 07/21/2025 (MT Newswires) -- Autolus Therapeutics ( AUTL ) said Monday that the European Commission has issued marketing authorization for Aucatzyl to treat patients 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval was based on the results of a clinical study published in November 2024, the company said, adding it applies to all 27 European Union member states, Iceland, Norway and Liechtenstein.

Autolus Chief Executive Christian Itin said the company is evaluating marketing entry opportunities in EU countries.

Aucatzyl, or obecabtagene autoleucel, is an autologous CD19 CAR T cell therapy approved by the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency.

Shares of Autolus were up more than 10% in recent premarket activity Monday.

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