Tens of thousands more women at increased risk of breast cancer could now benefit from a proven risk-reducing drug on the NHS, after it was licensed in a new use to help prevent the disease.
Anastrozole, which has been used for many years as a breast cancer treatment, has been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) as a preventive option – which it is hoped could help prevent around 2,000 cases of breast cancer in England.
The drug, which is off-patent, has been shown in trials to reduce the incidence of the disease in post-menopausal women at increased risk of the disease by almost 50%.
It was first recommended as a preventive option by the National Institute for Health and Care Excellence in 2017, however, with the treatment being unlicensed in this use, uptake has remained low.
Thanks to a pioneering Medicines Repurposing Programme led by NHS England, the drug has today been granted a new indication by the MHRA as a preventive option for women at increased risk, including those with a significant family history of the disease.
Around 289,000 women at moderate or high risk of breast cancer could be eligible for the drug, and while not all will choose to take it, it is estimated that if 25% do, around 2,000 cases of breast cancer could potentially be prevented in England, while saving the NHS around £15 million in treatment costs.
NHS chief executive, Amanda Pritchard, said: “It’s fantastic that this vital risk-reducing option could now help thousands of women and their families avoid the distress of a breast cancer diagnosis.
“Allowing more women to live healthier lives, free of breast cancer is truly remarkable, and we hope that licensing anastrozole for a new use today represents the first step to ensuring this risk-reducing option can be accessed by all who could benefit from it.
“This is the first drug to be repurposed through a world-leading new programme to help us realise the full potential of existing medicines in new uses to save and improve more lives on the NHS. Thanks to this initiative, we hope that greater access to anastrozole could enable more women to take risk-reducing steps if they’d like to, helping them live without fear of breast cancer.”
History
Lesley-Ann Woodhams, 61, was offered anastrozole off-label for the prevention of breast cancer due to being at increased risk of developing the disease, and having a family history of breast cancer. Lesley-Ann completed the full five-year course of anastrozole in January 2023.
She said: “Taking anastrozole was an easy decision for me, as I’d watched my mum battle breast cancer and my risk was very high. Anastrozole reduced my risk of developing breast cancer, meaning I could live a life without constantly worrying or giving a thought to what could be if I’d developed breast cancer. It really was a gift, it gave my family and myself peace of mind and more importantly, a continued future to look forward to. I’m grateful for every day I took this drug – it was life-changing. Anastrozole has allowed me to continue living my life as I’d planned.”
Breast cancer remains the most common cancer in England, with 47,000 people being diagnosed each year. Thanks to advances in screening, treatment and care alongside NHS awareness campaigns, more women are surviving the disease than ever before.
Anastrozole today becomes the first medicine to be repurposed through a new multi-agency national programme that looks at using existing medicines in new ways to benefit patients and the NHS.
The Medicines Repurposing Programme, set up in 2021, is hosted by NHS England and supported by DHSC, the MHRA, NICE, and the NIHR, and builds on the innovation in medicines repurposing seen during the COVID-19 pandemic, which saw tocilizumab, an arthritis drug, and dexamethasone, a widely available steroid, repurposed as treatments for COVID-19.
The licensing work was undertaken by Accord Healthcare on a not-for-profit basis, after Accord Healthcare was selected through an open competitive process. The Medicines Repurposing Programme will now work with the MHRA and the British Generic Manufacturers Association to ensure other companies that make anastrozole adopt the new licensed indication.
