Patients in England with an aggressive form of leukaemia will be offered a personalised “living drug” on the NHS within weeks, after health chiefs approved a new immunotherapy that put more than three quarters of patients into remission in trials.
NHS England said obe-cel – a type of CAR T-cell therapy also known by the brand name Aucatzyl – will be made available to adults aged 26 and over with B‑cell acute lymphoblastic leukaemia (ALL) whose cancer has either returned or failed to respond to previous treatment. Around 50 patients a year in England are expected to receive it.
Described as a “living medicine”, the therapy involves collecting a patient’s own immune cells, reprogramming them in a laboratory so they can recognise and attack cancer cells, and then infusing them back into the bloodstream. In a key clinical trial, 77% of patients saw their leukaemia go into remission following treatment with obe-cel.
Professor Peter Johnson, NHS England’s national clinical director for cancer, said the cutting-edge therapy could transform outcomes for people facing this fast-growing blood cancer. He said it had shown “real promise in trials” and could allow patients “to live free from cancer for longer – and, for some, it could offer the hope of a cure”.
The therapy will be delivered through specialist CAR‑T centres across the country and is expected to reach patients faster than usual after being backed by the National Institute for Health and Care Excellence (NICE). NHS England will use interim funding from the Cancer Drugs Fund so hospitals can begin offering the treatment ahead of the standard 90‑day implementation period.
Eligible patients will receive two intravenous infusions of obe-cel, ten days apart. Unlike earlier CAR‑T therapies, it has been designed with the potential to be given in an outpatient setting, which could shorten hospital stays and make it easier for older or less fit patients to access the treatment once services are fully established.
Trial data show that, of those who responded to obe-cel, about half had no detectable cancer three and a half years after treatment. On average, the therapy gave patients nearly 16 additional months of life. The drug was also associated with lower toxicity than many first‑generation CAR‑T treatments, with most side effects rated mild to moderate. The most common was cytokine release syndrome – an immune reaction that can cause flu‑like symptoms when the engineered cells begin attacking the cancer.
Acute lymphoblastic leukaemia is an aggressive cancer of the blood and bone marrow, with around 800 people diagnosed each year in the UK, about half of them adults. For patients with aggressive forms of the disease treated with chemotherapy, who currently make up the majority of cases, data show average survival of about 10 months after treatment.
Harry, a 19‑year‑old student from Harrogate, received obe-cel in 2024 as part of a clinical trial after being diagnosed with B‑cell ALL. “I feel so lucky to have had access to such a wondrous treatment,” he said. “Not only did it work better than my doctors thought it would, it worked without many of the horrible side effects you can get from other treatments. The biggest thing it offers is hope. When you’re facing a situation like mine, hope is the most valuable thing you can have.”
Health minister Ashley Dalton called the decision “excellent news for patients and their families”, saying it showed the NHS was “at the forefront of medical innovation”. She said the government’s 10‑Year Health Plan aimed to harness the UK’s life sciences sector to deliver “innovative therapies that save lives” while supporting treatments with fewer side effects and shorter hospital stays.
The therapy was researched, developed and will be manufactured in the UK by Autolus Therapeutics, a spin‑out from University College London. Production will take place in Stevenage, which hosts a major cluster of cell and gene therapy companies. Fiona Bride, interim chief commercial officer at NHS England, said the journey of obe-cel from UK university research to NHS treatment was “a success story that’s made in Britain” and showed how the country’s life sciences strengths could be translated into better care.
Leukaemia charities welcomed NICE’s decision. Fiona Hazell, chief executive of Leukaemia UK, said it was “a significant step forward in expanding treatment options” and highlighted that obe-cel is the first CAR‑T therapy specifically designed with outpatient delivery in mind. She said this could improve access “particularly for older patients or those with comorbidities” and expressed hope it might eventually be provided in local settings or even patients’ homes.
Henny Braund, chief executive of the blood cancer charity Anthony Nolan, said B‑cell ALL remained “an aggressive disease with a poor prognosis” and that additional options were still needed despite recent advances. She said the new therapy’s availability on the NHS marked “a significant step” for adults with relapsed or refractory disease.
Obe-cel is the latest in a growing range of personalised CAR‑T therapies offered by the NHS since it became the first health system in Europe to provide such treatments in 2018. Dr Claire Roddie, a consultant haematologist at University College London Hospitals who has worked on obe-cel since 2017, said many more patients now stood to benefit. She said the teams involved in developing and testing the treatment could “feel immensely proud of this achievement”, which she believes will help save more lives.