Thousands of people a year could benefit from new twice-a-day tablet for advanced breast cancer
We've published final draft guidance recommending capivasertib with fulvestrant, which means the treatment will be funded immediately through the Cancer Drugs Fund.
We've recommended capivasertib (also called Truqap and made by AstraZeneca) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread.
We’re looking at capivasertib with fulvestrant for people whose cancer has come back or got worse after treatment with a type of drug called a CKD 4 and 6 inhibitor and an aromatase inhibitor, a type of hormone therapy.
Our final draft guidance recommends capivasertib with fulvestrant for people with hormone receptor (HR)-positive HER2-negative breast cancer that has 1 or more PIK3CA, AKT1 or PTEN gene alterations and has spread within the breast tissue (locally advanced) or to other parts of the body (metastatic).
Today’s positive decision comes after we requested further analyses from the company following the first committee meeting about capivasertib’s long-term effectiveness compared with existing treatments.
The independent appraisal committee was able to apply a severity modifier of 1.2. This allows medicines that are used to treat conditions classed as high or medium severity to have a higher threshold at which they can be considered cost-effective.
Given as a twice-a-day tablet, capivasertib is a targeted treatment called a kinase inhibitor. It works by blocking the action of an abnormal protein that tells cancer cells to multiply. This helps slow or stop the spread of cancer cells. Results from a clinical trial showed that capivasertib plus fulvestrant increased the time before the cancer got worse by around 4.2 months compared with placebo plus fulvestrant.
Although capivasertib plus fulvestrant has not been directly compared in a clinical trial with 2 treatments we already recommend - alpelisib plus fulvestrant and everolimus plus exemestane - indirect comparisons suggest that it is likely to work as well as these.
Helen Knight, director of medicines evaluation at NICE, said: “The patient experts described the devastating impact that being diagnosed with advanced breast cancer has on people’s lives. They also highlighted the value of having a well-tolerated treatment that delays their cancer getting worse and targets AKT1 or PTEN gene alterations, noting that there are currently none available."
People with advanced breast cancer would value treatments like capivasertib that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects.
We are therefore pleased the company has worked with us so that we are able to recommend this promising new treatment as a good use of NHS resources and value for money for taxpayers.
In 2020 in England, 40,192 people were diagnosed with breast cancer, approximately 14.8% of who had advanced stage disease when they were diagnosed.
Hormone receptor (HR)-positive HER2-negative advanced breast cancer is incurable and the aim of treatment is to delay it getting worse and extend how long people live. If the cancer has alterations in the PIK3CA, AKT1 or PTEN genes, outcomes appear to be worse.
Today’s recommendation means we’ve approved 24 out of the 25 breast cancer treatments we’ve assessed over the past 7 years.