Autolus’s AUCATZYL (Obecabtagene Autoleucel) Approved in EU Following U.S. Clearance

Published on Autolus Therapeutics News Releases

Autolus’s CAR‑T therapy, AUCATZYL (obecabtagene autoleucel), has received marketing authorization from the European Commission for adults aged 26 and older with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia. This follows U.S. FDA approval in November 2024, for patients aged 18 and older. In the pivotal FELIX trial, 76.6 percent of participants achieved complete response or complete response with incomplete hematologic recovery, with a durable median response duration of 21.2 months. The design incorporates a fast off‑rate CD19 binding domain to reduce cytokine release and minimize CAR‑T exhaustion, with no REMS requirement in the U.S. and a favorable toxicity profile.

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👉 Autolus Therapeutics’ CAR‑T Therapy AUCATZYL® (obecabtagene autoleucel) Granted European Marketing Authorization for Adult Patients

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