NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients (≥26 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)¹

Core Insights - Autolus Therapeutics plc announces that AUCATZYL (obecabtagene autoleucel) has received draft guidance from NICE recommending its use in the NHS for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - AUCATZYL will be available through routine commissioning by the NHS in England and Wales, with plans for imminent launch [1][2] - The therapy has received conditional marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) based on the results of the FELIX study [2][6] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [4] - The company utilizes proprietary T cell programming technologies to create targeted and controlled T cell therapies [4] Product Information - AUCATZYL is a CD19 CAR T cell therapy designed to improve clinical activity and safety compared to existing therapies [5] - It features a fast target binding off-rate to minimize excessive activation of T cells [5] - The therapy was approved by the FDA in November 2024 and received conditional marketing authorization from both MHRA and EMA in 2025 [5][6] Industry Context - The announcement of AUCATZYL's availability is seen as a significant advancement in treatment options for patients with aggressive B-cell ALL, which has a poor prognosis [3] - Collaboration among organizations like Anthony Nolan, Leukaemia Care, and Leukaemia UK has been crucial in ensuring patient perspectives were included in the NICE evaluation process [3]