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EU Approves Autolus' AUCATZYL® CAR T for Relapsed/Refractory B-ALL
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Autolus Therapeutics has marked a pivotal moment in the fight against a highly aggressive blood cancer with the European Commission (EC) granting marketing authorization for AUCATZYL® (obecabtagene autoleucel, or obe-cel). This advanced CAR T cell therapy is now approved for adult patients aged 26 and older battling relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL), offering a much-needed new lifeline where conventional treatments have historically yielded very poor outcomes. This significant EC approval builds on prior authorizations from the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), solidifying obe-cel's global recognition.

The foundation of this approval lies in the robust clinical evidence from the FELIX study, an open-label, multi-center, single-arm trial, the results of which were published in the prestigious New England Journal of Medicine in November 2024. In the pivotal cohort of patients, obe-cel demonstrated an impressive 76.6% complete response/complete response with incomplete hematological recovery (CR/CRi) rate following at least one infusion. Crucially, the median duration of response for all infused patients was a durable 21.2 months, with estimated 6- and 12-month event-free survival rates of 65.4% and 49.5%, respectively. These figures represent a substantial improvement over the grim median overall survival of only eight months typically seen with standard treatments for r/r B-ALL.

Beyond its striking efficacy, obe-cel also exhibited a favorable and manageable toxicity profile. While some common non-laboratory Grade 3 or higher adverse reactions included infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%), the rates of severe CAR T-specific toxicities were remarkably low. Cytokine release syndrome (CRS), a well-known side effect of CAR T therapies, occurred in 68.5% of patients, but only 2.4% experienced Grade 3 or higher events. Similarly, immune effector cell-associated neurotoxicity syndrome (ICANS) developed in 22.8% of patients, with only 7% experiencing Grade 3 or higher events. This low toxicity profile, combined with the high and durable response rates, positions AUCATZYL® as a critical new treatment option for a patient population with extremely limited therapeutic avenues. Autolus Therapeutics is now actively evaluating market entry opportunities across EU countries to bring this innovative therapy to patients in need.

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