Britain's National Institute for Health and Care Excellence (NICE) has recommended Autolus’ CAR-T therapy, Aucatzyl, for routine National Health Service (NHS) use in England in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
According to the committee, evidence suggests Aucatzyl improves how long people live compared to other immunotherapies used at this stage of treatment. The therapy, says NICE, has the potential to increase patient’s likelihood of going into remission and has lower toxicity.
The positive recommendation from NICE, published as draft guidance, indicates that there is enough evidence to show that the therapy provides benefits and value for money, so it can be used routinely across the NHS.
Aucatzyl, a CD19-directed genetically modified autologous T-cell immunotherapy, was approved for relapsed or refractory ALL by the U.S. FDA in November 2024 and authorized by UK’s MHRA in April 2025. The European Commission granted marketing authorization for Aucatzyl’s use in July 2025.
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