European Commission Grants Marketing Authorization for Autolus Therapeutics' CAR T Therapy AUCATZYL for Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

Reuters
07/21
European Commission Grants Marketing Authorization for Autolus <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' CAR T Therapy AUCATZYL for Adult Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

LONDON and GAITHERSBURG, Md., July 21, 2025 - Autolus Therapeutics plc (Nasdaq: AUTL), a biopharmaceutical company focusing on next-generation T cell therapies, announced that the European Commission $(EC)$ has granted marketing authorization for their CAR T Therapy, AUCATZYL® (obecabtagene autoleucel or "obe-cel"). This approval is for adult patients 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use $(CHMP)$, as well as conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and approval from the U.S. Food and Drug Administration (FDA). The EC approval is applicable across all 27 European Union Member States, in addition to Iceland, Norway, and Liechtenstein. Autolus is now exploring market entry opportunities within these regions.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Autolus Therapeutics plc published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9497344-en) on July 21, 2025, and is solely responsible for the information contained therein.

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