Legislation to speed up cutting-edge blood cancer treatments comes into play
United Kingdom
Today, 23 July, new regulations have been announced that will allow hospitals to manufacture advanced treatments like CAR T-cell therapy on site - rather than sending cells hundreds of miles away and waiting weeks.
In a world first, Medicines and Healthcare products Regulatory Agency (MHRA) introduced regulations that will allow personalised medicines to be prepared in small or individual batches, bringing care closer to the patient.
If these new rules mean people with blood cancer can be treated faster and closer to home, this could be transformational
- Blood Cancer UK's Tracey Loftis
In 2018, adults with blood cancer in England were the first in Europe to receive innovative CAR-T therapy. It has already transformed outcomes for some people with blood cancer. Blood cancer is the fifth most common cause of cancer and includes the conditions, leukaemia, lymphoma, myeloma, MPNs and MDS.
Yet not everyone who could benefit from this treatment has been able to receive it in time. The therapies can also be more demanding to deliver and occur at specialised centres, often requiring multiple treatment episodes over a longer duration, stretching the workforce and systems in place.
Now UK hospitals, ambulances and local care have a way to carry out the final manufacturing steps for personalised or time-sensitive treatments on-site, using regulated protocols. This process brings it in line with how chemotherapy or antibiotics are prepared locally, but with the strict safeguards for more advanced therapies. The regulations mean a central control site will provide detailed instructions and oversight, while hospitals can complete the process closer to the patient.
Reflections from someone afffected by blood cancer
Jacquie Hellowell, received CAR T-cell therapy for lymphoma
"My T cells were sent abroad to be trained to do the big CAR-T cell therapy job - kill the cancerous B cells. For future CAR-T patients to have their T cells trained in the same hospital will be a great step forward."
Speaking about the announcement, Tracey Loftis, Deputy Director of Policy and Influencing at Blood Cancer UK, 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.”
Blood Cancer UK-funded research is investigating a new rapid process
Blood Cancer UK-funded research, is investigating a new rapid production process to produce CAR-T cells in only three days, allowing people on the trial to start treatment more quickly.
Dr Charlotte Graham is leading the project.
Also speaking about the news, the Health and Social Care Secretary commented.
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 nof miles away.”
- Wes Streeting
