New UK rules allow hospitals to prepare advanced blood cancer treatments locally, reducing delays for patients.
New regulations introduced on 23 July will allow hospitals across the UK to manufacture personalised cancer therapies on-site, instead of sending cells to distant labs.
The Medicines and Healthcare products Regulatory Agency (MHRA) has created the legal framework, said to be the first of its kind globally, allowing treatments to be prepared in small batches for individual patients.
Health and social care secretary Wes Streeting said: “This world-first legislation is a game-changer for patients. Cancer treatments tailored in days, not months.
“Life-saving therapies made at your bedside, not hundreds of miles away.”
This development brings therapies such as CAR T-cell therapy – which engineers a patient’s own immune cells to fight cancer – closer to those who need them.
CAR T-cell therapy involves removing T-cells from the patient, modifying them in a lab to recognise cancer, and then reinfusing them. Previously, this process could take weeks as cells were transported to specialist centres.
Under the new rules, NHS hospitals, ambulances and local care services can complete final manufacturing steps on-site, guided by centralised control centres. These local procedures follow the model of how chemotherapy and antibiotics are prepared in pharmacies, but under tighter protocols suited for advanced treatments.
In 2018, England became the first country in Europe to offer CAR T-cell therapy to adults with blood cancer. Blood cancer – which includes leukaemia, lymphoma, myeloma, myeloproliferative neoplasms (MPNs) and myelodysplastic syndromes (MDS) – is the UK’s fifth most common cause of cancer.
Access to CAR T-cell therapy remains limited, due to the complexity and time involved in delivering it. Many patients need multiple sessions at highly specialised centres, placing pressure on stretched services.
Tracey Loftis is deputy director of policy and influencing at Blood Cancer UK.
She said: “The UK is the first country in the world to introduce this kind of legal framework.
“It’s encouraging to see a commitment to personalised, cutting-edge care.
“We know that CAR T-cell therapy can be a life-saving treatment for some people with blood cancer.
“Our UK Blood Cancer Action Plan identified that everyone across the UK must be able to access the drugs and treatment they need, and address the barriers that prevent people from receiving them in a timely matter.
“If these new rules mean people with blood cancer can be treated faster and closer to home, this could be transformational.”
