Patients with an aggressive form of leukaemia will be able to receive a breakthrough immunotherapy on the NHS that saw over three quarters of patients go into remission in trials.
The CAR T-cell therapy – known as ‘obe-cel’ – involves taking a patient’s immune cells and reprogramming them in a lab to identify and target their cancer, before returning them to the body as ‘living medicine’.
NHS England today announced that the personalised therapy would be available on the NHS within weeks through specialist centres.
Described by patients as having a “wonderous” effect in trials, England’s top cancer doctor said the treatment could give those with aggressive leukaemia the chance to live free from cancer for longer and for some could even offer “hope of a cure”.
Eligible patients will receive two doses of CAR-T therapy intravenously, ten days apart, with the treatment being delivered at selected specialist CAR-T centres across the country.
The treatment will be available to people aged 26 and over living with B-cell acute lymphoblastic leukaemia which has returned or not responded to previous treatment, following approval from the National Institute for Health and Care Excellence.
It is estimated that is could be administered to around 50 patients each year in England.
In a clinical trial, 77% of patients saw their cancer enter remission after treatment with obe-cel, with half of those showing no signs of detectable cancer after three and a half years. On average, the treatment gave patients 15.6 months additional months of life.
The treatment – which has been researched, developed and manufactured in the UK – was also found to have lower toxicity and was less likely to cause serious side effects than other CAR (chimeric antigen receptor) T-cell therapies.
Professor Peter Johnson, NHS National Clinical Director for Cancer, said: “This cutting-edge therapy has shown real promise in trials and could give patients with this aggressive form of leukaemia a chance to live free from cancer for longer – and, for some, it could offer the hope of a cure.
“This ‘living medicine’ boosts a patient’s own immune system and then guides T-cells towards the cancer to kill it – it is fantastic to have another pioneering option available on the NHS, adding to our range of CAR-T therapies which are helping people with blood cancers live longer, healthier lives.”
Harry, a 19-year-old student from Harrogate, was treated with obecel for B-cell ALL as part of a clinical trial in 2024. He said: “I feel so lucky to have had access to such a wonderous treatment. 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.
“I think it’s brilliant obe-cel is now available on the NHS for people over the age of 26. 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 said: “This pioneering treatment is excellent news for patients and their families, demonstrating how the NHS is at the forefront of medical innovation.
“Our 10 Year Health Plan is about harnessing our world-leading life sciences sector to deliver treatments like this – innovative therapies that save lives.
“By supporting new treatments with fewer side effects and shorter hospital stays, we’re building an NHS fit for the future whilst cementing the UK’s position as a global leader in medical research.”
Fiona Bride, interim Chief Commercial Officer and Director of Medicines Value and Access at NHS England, said: “This is a success story that’s made in Britain, and shows how collaboratively we can bring to life the ambition of the 10 Year Health Plan, showcasing how the UK’s competitive edge in life sciences can translate to better outcomes and treatments for NHS patients.
“The journey of obe-cel from scientific research in a UK university to a safe, clinically and cost-effective treatment set to be delivered through the NHS specialist CAR-T network is a remarkable one and I am grateful to colleagues who have played their part along the way.”
Acute lymphoblastic leukaemia is an aggressive cancer in the blood and bone marrow, with around 800 people being diagnosed in the UK every year, around half of which are in adults.
Data shows patients with aggressive forms of the cancer receiving chemotherapy, the current routine standard of care, live for just 10 months on average after treatment.
Fiona Hazell, chief executive at Leukaemia UK, said: “We are delighted that this therapy will be available on the NHS and this is a significant step forward in expanding treatment options for people living with leukaemia.
“This treatment is unique as the first CAR-T therapy designed with the potential to be given in an outpatient setting, offering better accessibility particularly for older patients or those with comorbidities – and we hope to see it made available in local settings or patient homes in the near future. Leukaemia UK remains committed to supporting innovation and improving access to treatments to bring hope to people affected by leukaemia.”
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, which enables access to an innovative new CAR-T therapy, marks a significant step for patients with B-cell ALL in England and Wales.
“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.”
The therapy will be fast tracked to patients more quickly than the standard 90-day implementation period thanks to interim funding from the NHS’s Cancer Drugs Fund.
This is the latest personalised CAR-T therapy offered by the NHS in England since it was the first health system in Europe to offer CAR-T in 2018. The NHS now offers a range of CAR-T treatments for different forms of blood cancers to treat adults and children.
Dr Claire Roddie, UCLH consultant haematologist and associate professor at the UCL Cancer Institute said: “I am delighted to hear of NICE’s decision. Many more patients now stand to benefit from CAR-T cell therapy on the NHS. We have been working on proving the safety and efficacy of this drug for ALL since 2017 and it has brought together clinical and research teams from UCL and UCLH, with support from government and arms-length bodies like the NIHR and the BRC as well as the pharmaceutical industry.
“The many, many people involved in this work can feel immensely proud of this achievement which will help save the lives of many more patients.”
Aucatzyl (obecabtagene autoleucel) is manufactured by Autolus Therapeutics, a spin-out from University College London, and will be made in Stevenage, which is home to multinational pharmaceutical companies and the Cell and Gene Therapies Catapult.
Patients experienced mild to moderate side effects from the treatment, with Cytokine Release Syndrome the most common side effect, which happens when the immune system goes into overdrive after treatment, causing flu-like symptoms.
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