Friday, February 3, 2023

NHS England to fast-track prostate drug which can prolong survival by years

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A prostate cancer drug which can extend survival by years will be fast-tracked by the NHS.

Around 9,000 men with advanced disease will be eligible for darolutamide when the health service in England becomes the first in Europe to offer the drug. 

The deal has been made possible because of an international partnership set up in the wake of Brexit to speed up access to new medicines. 

Under the radical deal, darolutamide will be available free to the NHS while medicines authorities complete their appraisal.

Studies have found the drug gives men with advanced disease an extra two years on average, cutting mortality by one-third. 

The medicine was also found to improve quality of life in patients who have not received any other treatment.

It works by blocking androgen receptors in cancer cells, blocking the effect of testosterone that allows the cancer cells to survive and proliferate.

Darolutamide, also known by its brand name, Nubeqa®, is already available on the NHS for some patients who have localised prostate cancer.

The offer is now being expanded to cover those whose cancer has spread after NHS England struck another early access agreement after the Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug.  

‘Cutting edge drugs’

Amanda Pritchard, NHS England’s 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.”

Prostate cancer is the most common cancer in men and around 47,000 men are diagnosed with it annually. 

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.

A trial at almost 300 sites, including NHS hospitals, found patients given the combined treatment were 32.5 per cent less likely to die than with ADT and docetaxel alone.

On average survival was two years longer, the ARASENS trial found. 

After completing chemotherapy with docetaxel, men will continue to have their original hormone therapy alongside darolutamide in order to keep testosterone levels low and help the treatment work.

‘A drive to improve cancer outcomes’

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. 

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 the National Institute of Clinical Excellence (NICE).

NICE is currently evaluating whether to recommend the drug is routinely prescribed, with manufacturers providing the medicines at no cost, while the appraisal is completed. 

Antonio Payano, chief executive of 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.

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