The Institute of Cancer Research, London, UK, has welcomed the announcement by NICE that it will reconsider its decision not to recommend abiraterone as a first-line treatment for newly diagnosed, advanced prostate cancer.
An appeal panel today upheld a series of complaints from manufacturer Janssen, charities and prostate cancer specialists about NICE’s process in deciding not to make abiraterone available first line.
These included that the NICE committee had not assessed all available evidence, and had been ‘unreasonable’ in not taking into account the impact on men with prostate cancer who for various reasons are unable to have chemotherapy.
NICE to review the decision
The Institute of Cancer Research (ICR) now looks forward to the NICE committee meeting again to review the decision, and hopes men with advanced prostate cancer in England and Wales will shortly be able to benefit from the drug.
The ICR discovered abiraterone, and developed the targeted drug in clinical trials with its hospital partner, The Royal Marsden NHS Foundation Trust.
Results published three years ago by the STAMPEDE and LATITUDE trials showed that abiraterone as a first-line treatment extends the time men live without their disease coming back, and offers them a better quality of life than other treatment options, in particular docetaxel chemotherapy, the comparator considered by NICE.
More recent long-term follow up data from STAMPEDE shows that the average survival gain for those with advanced disease is between two and three years.
Better quality of life
But NICE’s refusal to recommend abiraterone has left men in England and Wales who are first diagnosed with advanced prostate cancer with the options of only hormone therapy with docetaxel chemotherapy, or hormone therapy on its own. By contrast, men in Scotland have been able to access abiraterone has a first-line treatment since the beginning of the year.
Docetaxel chemotherapy often involves serious side effects, and many men with advanced prostate cancer can’t tolerate it or choose not to have it. In fact, only around a quarter of men receive chemotherapy meaning that at present three quarters of men are denied life-prolonging therapy.
Abiraterone has also been found to halve the risk of serious complications such as bone fractures and spinal cord problems from cancer when compared with a combination of hormone therapy and docetaxel chemotherapy. The ICR’s researchers therefore argue that it is a much kinder option.
Importantly, abiraterone offers additional benefits during the Covid-19 pandemic, as it can be taken as a tablet at home, avoiding hospital visits for chemotherapy, and comes with fewer risks to the immune system.
‘Game-changing targeted treatment’
Professor Nick James, Professor of Prostate and Bladder Cancer Research at the ICR and Consultant Clinical Oncologist at The Royal Marsden, led the STAMPEDE clinical trial and was one of the clinical experts involved in appealing the decision by NICE. He said:
“It’s great news that NICE will be reassessing its decision not to make abiraterone available for prostate cancer patients as a first-line treatment. Abiraterone truly is a game-changing targeted treatment that doesn’t just help men to live longer but also gives them a much better quality of life. I’m really optimistic now that it is finally going to be made available for many more men. The requirement to review the previous refusal means that important additional data from our STAMPEDE trial can be included in the evidence used.
“Our data clearly shows that abiraterone significantly improves quality of life compared with chemotherapy or hormone therapy alone, with long-term benefits that can last several years. Men in Scotland have been able to access abiraterone since the beginning of the year, so I would urge NICE’s committee to meet as soon as possible to ensure men in England and Wales don’t miss out any longer.
“Getting approval for abiraterone as a first-line treatment is taking frustratingly long. I would urge NICE to work together with the manufacturer and look at all the latest data, so that together they can come to an agreement for making abiraterone available that benefits everyone – and, above all, patients.”