Last week the Medicines Healthcare Regulatory Authority – MHRA – gave the green light for the drug to be marketed in England following trial results showing the treatment stopped the return of early stage breast cancers following initial treatments such as surgery or radiotherapy.
The National Institute for Health and Care Excellence (NICE) is expected to approve the treatment for NHS use within months.
Experts say the new therapy is the most significant breakthrough in this – the most common form of breast cancer – for two decades.
The combination therapy – Abemaciclib with fulvestrant (Verzenios) – was trialled in 5,637 patients in 600 hospitals in 38 countries across the world including the UK, the USA, Brazil, China, Russia and Japan.
It was given to patients with a form of breast cancer which grows in response to female hormone levels.
This form of breast cancer accounts for up to 70 percent of all 55,000 new breast cancers a year, and for those with certain high-risk features where cancer has already spread to lymph nodes, up to 30 percent of patients experiencing a recurrence within five years of treatment.
Taken as a twice-daily pill, Verzenio, also known as a CDK4/6 inhibitor, has been shown to block cancer cell proteins.
This prevents the cells from dividing and growing, helping to prevent relapse. The trial – known as MonarchE – found the drug reduced the risk of the cancer recurring by 32 per cent within the first three years. It is estimated around 5,000 patients a year would be eligible for the treatment.
Professor Stephen Johnston, head of The Breast Unit at the Royal Marsden NHS Foundation Trust, Professor of Breast Cancer Medicine at the Institute of Cancer Research, London, and lead investigator for the trial, said: “If you can stop cancer spreading you can ultimately cure more patients. Despite previously receiving the very best standard of care treatment, these breast cancer patients were at considerable risk of their disease returning.
“We are delighted with these compelling results from the trial, which was a huge international effort, translated into a groundbreaking treatment option for these breast cancer patients who have a high risk of their cancer recurring. This group of patients has had no new treatments for 20 years and we anticipate funding for this treatment on the NHS.”
The treatment has already received approval from regulators in America, China, Brazil, Japan and the EU.
Breast cancer has become the most commonly diagnosed cancer type in the world, according to the World Health Organisation.
Emma Sola, a 48-year-old secondary school teacher from Brighton was diagnosed with Stage 3 breast cancer in 2018 which had spread to her lymph nodes.
She underwent a mastectomy and was treated with chemotherapy, radiotherapy, and hormone therapy. Because she was considered at high risk of recurrence she was accepted onto the monarchE at the Royal Marsden.
She finished the trial drug in February 2019. She said: “When I found out I had breast cancer, I was absolutely horrified. I was told my diagnosis meant my prognosis was poor and I had a low chance of surviving beyond ten years. My son was just eight at the time and I was frightened for him. I felt so lucky to be involved in the trial.
“It gave me a feeling of security and I felt I was giving myself every opportunity to have a life in the future. My treatment has also given me a new lease of life. I have been promoted to head of English at my school and I am renovating a new house – I feel I can make plans. I now feel as if cancer is no longer in control of my life – I am.”