Thousands of women with advanced breast cancer in England and Wales are to be offered a “gamechanging” twice-a-day pill on the NHS after a U-turn by the medicines watchdog.
Experts hailed the decision as a “landmark moment”. As many as 3,000 women every year could benefit from capivasertib for hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread.
The drug, also known as Truqap and made by AstraZeneca, blocks an abnormal protein molecule AKT that drives cancer cells to multiply – helping to slow or stop the spread of the disease.
Claire Rowney, the chief executive of charity Breast Cancer Now, welcomed the green light from the National Institute for Health and Care Excellence (Nice) but said its initial rejection of the pill had led to treatment delays.
She said: “This happens too often and urgent action must be taken to ensure the quick approval of breast cancer drugs so they can be made available promptly to those who need them.
“NHS England must now put in place prompt genetic testing to ensure those eligible receive capivasertib without further delay. The Scottish Medicines Consortium must also consider this treatment at pace now, so that we see it made available to all who need it across the UK.”
Results from trials show that capivasertib plus the hormone therapy fulvestrant increased the time before cancer got worse by about 4.2 months compared with placebo plus fulvestrant – from 3.1 months to 7.3 months.
The Institute of Cancer Research (ICR) in London welcomed the approval for a “gamechanging” drug after decades of research by its scientists.
The drug is suitable for patients’ tumours with mutations or alterations in the PIK3CA, AKT1 or PTEN genes. These are found in about half of patients with this form of breast cancer.
Prof Nicholas Turner, from the ICR and the Royal Marsden NHS Foundation Trust, led a key trial into the drug.
He said the Nice approval meant “thousands of NHS patients with advanced breast cancer with these specific biomarkers can now receive this innovative targeted treatment to keep their cancer from progressing for longer”.
Prof Paul Workman, the former chief executive of the ICR and researcher in the AKT drug discovery project, said: “I am delighted to celebrate this landmark moment and see capivasertib become available on the NHS.
“It’s immensely gratifying that years of collaboration have contributed to this new cancer drug, which has the potential to improve the lives of so many NHS patients living with advanced breast cancer.”
Helen Knight, director of medicines evaluation at Nice, said the watchdog had heard about the “devastating impact that being diagnosed with advanced breast cancer has on people’s lives”.
She said she was pleased AstraZeneca had worked with Nice to enable it “to recommend this promising new treatment as a good use of NHS resources and value for money for taxpayers”.
