World first as life-saving cancer drugs to be mixed at patients' bedsides

Telegraph

4 days ago

Cancer patients will get personalised drugs made at their bedside under new laws, The Telegraph can reveal.
The UK is the first country in the world to relax the strict manufacturing rules that cause delays to time-sensitive treatments.
An increasing number of new medicines, including for cancer and rare genetic disorders, involve creating a bespoke drug for each patient by collecting their cells and modifying them in a laboratory, before they are injected back into the patient.
But because the samples have to be taken and edited in specialist facilities – often hundreds of miles away – patients are too often facing delays. They may become too unwell to receive the drug, or the medicine itself may not survive the journey because of its short shelf-life.
From now, the last of these steps can be completed closer to the patient, reducing the time it takes to produce a life-saving treatment from months to just days, the medical regulator said.
'Flexible, responsive system'
The new laws, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), will mean the drugs can be manufactured where the patient is – and given to them in hospital or their own homes.
Writing in The Telegraph, Lawrence Tallon, the new chief executive of the MHRA, said it was about creating 'a more flexible, responsive system that meets the needs of modern medicine' rather than forcing 'the medicine to fit an outdated system'.
'Some of these advanced therapies are made using a person's own cells. Others are built around their genetic code. A few are so sensitive they can't be frozen or stored – they have to be given to the patient within mere minutes of being made. That's a world away from how medicines are typically mass-made and distributed today,' he said.
'In these cases, delays can be critical. Some patients have become too unwell to receive their treatment in time. In others, the medicine simply didn't survive the journey.'
He added: 'Hospitals can now carry out the final steps of manufacturing on-site – under the same strict standards, but far more quickly.
'That means a cancer patient could now have their immune cells collected, modified, and returned at the same hospital. A child with a rare genetic disorder can receive a therapy made at their bedside.'
'Personalised therapies'
Mobile units will also be deployed to finish the manufacturing of the drugs for patients who are too sick to leave their homes or need to limit hospital visits because of weakened immune systems.
The MHRA said the move mirrored how chemotherapy and antibiotics are prepared locally, but stressed that there would still be strict safeguards and regulatory protocols.
There will also be a 'central control site' that will oversee the personalised therapies being completed in hospitals.
Wes Streeting, the Health Secretary, said it was a 'game-changer'. 'Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away,' he said.
'Our Plan for Change promised to build an NHS fit for the future. Today we're delivering on that pledge by bringing cutting-edge care directly to patients when they need it most.
'This type of therapy means patients can be treated and return home more quickly.'
One example of a personalised treatment that is set to become more accessible for patients is CAR-T cancer therapy.
It involves genetically modifying a blood cancer patients' immune cells so that the immune system recognises and kills the cancer cells that would otherwise go undetected by the body and continue to spread.
Previously, hospitals were only able to offer these treatments through complicated, one-off arrangements.
The changes have already come into effect after the legislation, known as The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, was passed last month.
It covers a range of innovations, including cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products, and medicinal gases.
Lord Vallance, the science minister and Government's former chief scientific officer, said the 'world-first framework gives the NHS and innovators a clear, safe way to bring advanced treatments from the lab to the patient's bedside'.
'It's a powerful example of how smart regulation can help more patients benefit from the best of British science.'
'Modern medicine needs a modern delivery system'
By Lawrence Tallon
For most medicines, the system works well enough. Medicines are made in bulk, boxed up, and shipped off to where they're needed in the world. It's how care has been delivered for decades. But a new generation of personalised therapies is beginning to challenge that model – and unless we adapt, patients could miss out.
Some of these advanced therapies are made using a person's own cells. Others are built around their genetic code. A few are so sensitive they can't be frozen or stored – they have to be given to the patient within mere minutes of being made. That's a world away from how medicines are typically mass-made and distributed today.
In these cases, delays can be critical. Some patients have become too unwell to receive their treatment in time. In others, the medicine simply didn't survive the journey. We need a more flexible, responsive system that meets the needs of modern medicine, not force the medicine to fit an outdated system.
That's why this week, the UK became the first country in the world to introduce a new legal framework that allows these advanced medicines to be made at the point of care. Under new regulations introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), hospitals can now carry out the final steps of manufacturing on-site – under the same strict standards, but far more quickly.
That means a cancer patient could now have their immune cells collected, modified and returned at the same hospital. A child with a rare genetic disorder can receive a therapy made at their bedside. No more shipping cells hundreds of miles away and hoping they survive the journey back. It also offers a safer alternative for people too unwell to travel, or whose immune systems make hospital visits risky.
'Supporting early access to promising treatments'
This is part of a wider effort to modernise the way we support innovation in the UK. We've shortened the time it takes to approve clinical trials to 40 days. We've introduced new routes for authorising medicines already approved by trusted international regulators. And where the evidence is strong and the need is urgent, we support early access to promising treatments.
We're paying particular attention to rare diseases, where patients often face the longest waits for new treatments. While each condition may affect only a few people, the overall impact is large: around 3.5 million people in the UK, and an estimated 300 million globally, live with a rare condition. Yet developing treatments is often more difficult, with fewer clinical trial participants and less commercial return.
That's why we're offering targeted support. For companies working on rare disease therapies, we've reduced or waived fees and increased access to expert scientific advice. The aim is to make it simpler and more affordable to bring forward safe treatments where there is high need and few other options.
We're also supporting smarter ways to generate evidence. For very rare conditions, large-scale trials aren't always possible. We're working with researchers to use high-quality real-world data, like NHS records and patient registries, so that safe and effective treatments aren't held back for lack of traditional trial data.
Medical innovation doesn't end with discovery or what's in the vial. It's also about tackling the barriers that stop new treatments reaching patients. That means creating a safe system built for tomorrow's medicines – especially for people with the fewest options – whether by changing how they're approved, how trials are run, or how evidence is gathered.
After all, a life-changing treatment only matters because we can deliver it when and where the person needs it.