The NHS in England will become the first in Europe to roll out Darolutamide to patients whose prostate cancer has spread to other parts of the body.
Around 9,000 men with one of the most advanced forms of prostate cancer will be eligible for a new life-extending treatment thanks to a fast tracked deal by the NHS.
Studies show the chances of living longer are increased by one third in men who were previously left untreated.
The drug works by blocking androgen receptors in cancer cells, which in turn blocks the effect of testosterone that allows the cancer cells to survive and multiply.
Darolutamide, also known by its brand name, Nubeqa®, is already available on the NHS for some patients who have localised prostate cancer but this offer is now being expanded to cover those whose cancer has spread after NHS England struck another early access agreement.
The agreement has been reached after the UK medicines regulator, the MHRA approved the treatment through Project Orbis, which is an international partnership between medicines regulators in the UK, US, Australia and others, set up to speed up the approval process for promising cancer treatments.
This is the latest example of the NHS delivering on the Long Term Plan commitment to ensure patients across the country have access to the latest and most effective treatments available.
NHS executive Amanda Pritchard said: “It is fantastic that patients in England will be the first in Europe to receive this treatment for a really advanced and aggressive form of prostate cancer thanks to the NHS fast tracking a new drug deal.
“The NHS is continuing to lead the way in securing the best possible treatments for patients – this is the latest in a long list of cutting-edge drugs that we have secured to help people to live longer with cancer, making a huge, life-changing difference to patients and their families across the country”.
Prostate Cancer is the most common cancer in men and around 47,000 people are diagnosed with it every single year in England. Almost 9,000 people go on to suffer from this aggressive form of metastatic prostate cancer.
Darolutamide is usually taken as a tablet with food and in combination with androgen-deprivation therapy (ADT) and docetaxel chemotherapy – patients were 32.5% less likely to die than with ADT and docetaxel alone, based on the ARASENS trial, which took place at almost 300 sites around the world, including several NHS hospitals.
After completing chemotherapy with docetaxel, patients will continue to have their original hormone therapy alongside darolutamide in order to keep testosterone levels low and help the treatment work.
NHS National Director for Cancer Professor Peter Johnson said: “Prostate cancer is the most common cancer among men and it is vital the NHS continues to diagnose it as early as possible and uses the widest possible range of cutting-edge treatments give people the best chances of surviving.
“This innovative treatment builds on the NHS ambition continuously to improve cancer care and survival rates, and will help thousands of men diagnosed with prostate cancer to live a better quality life and reduce their risk of dying.”
Newly approved by the MHRA, the NHS will begin to offer the new drug to eligible prostate cancer patients within weeks, following the latest early access agreement reached by NHS England and the drug’s manufacturer, Bayer and supported by NICE.
Darolutamide will be available on a budget-neutral basis to the NHS while NICE completes its ongoing appraisal.
One man to have benefitted from the treatment already is 79-year-old Roger Downes from Colchester who took part in the ARASENS trial and is now looking forward to an 80th birthday on the Rhine.
Having been diagnosed with metastatic prostate cancer by his oncologist at Colchester Hospital and placed on the trial, Roger was declared cancer free around four years ago and has stayed that way ever since.
Roger said: “It was an extremely positive experience and the outcome has been amazing. At first, we didn’t know if I was on the placebo or the drug, but after being on it for a time – when I went for my regular 12-week appointment with the oncologist – my PSA had become undetectable and it has been for three or four years – or maybe even longer.
“Now I am just leading a normal life and looking forward. I play the trombone in a local swing band and my partner and I are planning a river cruise on the Rhine next year to celebrate my 80th.
“I had no adverse side effects from the drug and still take it now. I just wake up in the morning and think, that’s another one – I just look forward.”
Roger took part in the ARASENS trial at Colchester Hospital, part of East Suffolk and North Essex NHS Foundation Trust (ESNEFT).
His consultant medical oncologist, Dr Dakshinamoorthy Muthukumar (Dr Kumar) was among the doctors to see up close the impact the treatment made to patients.
Dr Kumar said: “This drug is proven to have real benefits for patients and I have seen first-hand how it has saved lives, giving our patients in trials who have had limited success with other treatments, complete and long-lasting remission from cancer and hope of a future that is cancer-free.
“It is fantastic that the treatment will now be made available to eligible patients across the NHS and we can continue to expand the number and type of treatments we have available to beat cancer”.
Antonio Payano, CEO Bayer UK & Ireland said: “We are delighted that faster access to darolutamide has been made possible for men with prostate cancer in England. By working closely with the MHRA and NHS England, we have been able to make this therapy available ahead of a recommendation from NICE so that more patients can benefit.
“The collaboration has been based on a shared recognition of the value this new treatment option can provide as part of a drive to improve cancer outcomes”.
This is the fifth cancer drug which has been made available by the NHS in England through an early national access agreement following a Project Orbis licence, and follows similar NHS agreements for mobocertinib, osimertinib, atezolizumab, and cutting-edge therapy sotorasib which targets the so-called “death star” mutation.
Chiara De Biase, Director of Support and Influencing at Prostate Cancer UK, said: “Being told you have advanced prostate cancer can be devastating, and we urgently need new treatments to help these men live longer.
“That’s why it’s fantastic that thousands of men are being given early access to darolutamide alongside traditional hormone therapy and chemotherapy, which could massively improve their survival.
“This is great news for men, and we hope that this temporary approval leads to the treatment being rolled out permanently across the UK”.
Health and Social Care Secretary Steve Barclay said:
“Leaving the EU presented us with the opportunity to join Project Orbis, meaning we are the first in Europe to help to speed up the time it takes to get lifesaving new cancer medicines to around 9,000 men.
Thanks to this partnership, the NHS has struck a new deal that means patients with the most aggressive forms of prostate cancer will be among the first in Europe to benefit from this promising new treatment.
“We’re determined to improve outcomes and speed up diagnosis for cancer patients across England, and alongside fast-tracking new treatments, the NHS has opened over 90 community diagnostic centres, which have delivered over two million additional scans, tests and checks.”
Source: NHS / Public Health England