NICE recommends Autolus' AUCATZYL® for rare form of leukemia
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending AUCATZYL® (obecabtagene autoleucel, or “obe-cel”), developed by Autolus Therapeutics plc, an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (≥26 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
AUCATZYL will be available through routine commissioning by the NHS. Autolus intends to launch AUCATZYL in England and Wales imminently. Autolus also intends to pursue patient access to AUCATZYL through the Scottish Medical Consortium.
Dr. Christian Itin, Autolus Chief Executive Officer, said:
We believe AUCATZYL represents an important new treatment option for eligible adult r/r B-ALL patients. NHS clinical centres and UK patients participated in the development of AUCATZYL and we are looking forward to supporting patients and physicians in England and Wales now with the commercial product.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation for AUCATZYL in April 2025. The MHRA authorisation of AUCATZYL was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia, the results of which were published in the New England Journal of Medicine in November 2024.
Henny Braund, Chief Executive of Anthony Nolan, said:
B-cell ALL is an aggressive disease with a poor prognosis, and there remains a need for additional treatment options. Today’s announcement marks an important step towards enabling more patients in England and Wales to access this CAR T therapy. Anthony Nolan, together with our partners Leukaemia Care and Leukaemia UK, welcomes this progress and looks forward to working with the NHS to help make AUCATZYL available to adult relapsed or refractory B-cell ALL patients in due course.
Fiona Hazell, CEO, Leukaemia UK, said:
We are delighted that NICE has recommended AUCATZYL for use within the NHS in treating adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. This represents an important development in the availability of treatment options for people affected by this type of leukaemia. This decision reflects the value of collaboration between Leukaemia UK, Anthony Nolan and Leukaemia Care to ensure patient voices were included in the NICE evaluation process. We’re especially proud of our patient representative, whose compelling testimony was a vital part of the process. Leukaemia UK is proud to have contributed to this outcome, and we remain committed to supporting innovation and improving access to treatments that bring hope to people affected by leukaemia.
