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 and the drug should be available within weeks.
NHS England will become the first in Europe to roll out Darolutamide to patients whose prostate cancer has spread to other parts of the body.
Studies show the chances of living longer are increased by one third in men who were previously left untreated.
Prostate cancer is the most common cancer in men. Around 47,000 people are diagnosed with prostate cancer every year in England. Almost 9,000 people go on to suffer from this aggressive form of metastatic prostate cancer.
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.
Director of Support & Influencing at Prostate Cancer UK Chiara De Biase 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.”
The agreement has been reached after the UK medicines regulator, the MHRA approved the treatment through Project Orbis, an international partnership between medicines regulators in the UK, US, Australia and others, which speeds up the approval process for promising cancer treatments.
Amanda Pritchard, NHS chief executive, 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.”
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, the NHS says patients will continue to have their original hormone therapy alongside darolutamide in order to keep testosterone levels low and help the treatment work.
Professor Peter Johnson, NHS national director for cancer, said: “We know that prostate cancer is the most common form of cancer among men and it is vital the NHS continues to diagnose patients as early as possible and expand our arsenal of cutting-edge treatments in order to increase the chances of people surviving.
“This innovative treatment builds on the NHS ambition to improve cancer care and survival rates and will help thousands of men diagnosed with prostate cancer to live a better quality life, decreasing their chance of dying by one-third.”
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.
“It was an extremely positive experience and the outcome has been amazing,” said Roger. “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.
He added, “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.
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.
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