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The National Institute for Health and Care Excellence (NICE) has recommended a new combination treatment for locally advanced or metastatic hormone receptor (HR)-positive, HER 2-negative breast cancer for use on the NHS in England and Wales.
In final draft guidance, published on 11 April 2025, NICE approved capivasertib (Truqap; AstraZeneca), a twice-daily pill taken in combination with fulvestrant, which blocks the effects of AKT kinases proteins that enable cancer cell growth and multiplication.
NICE said that the treatment would be an option for around 1,100 adults whose cancer has recurred or progressed after treatment with a cyclin-dependent kinase (CDK) 4 and 6 inhibitor plus an aromatase inhibitor.
In a statement, also published on 11 April 2025, NICE added that the final draft guidance’s publication “means the treatment will be funded immediately through the Cancer Drugs Fund”.
HR-positive, HER 2-negative advanced breast cancer is incurable; however, treatment aims to slow the progression of the disease.
Data from clinical trials suggest that taking capiversatib with fulvestrant gives patients, on average, an additional four months before their cancer progresses compared with fulvestrant alone.
NICE said that the usual treatment used if cancer returns or progresses following a CDK 4 and 6 inhibitor with an aromatase inhibitor is either alpelisib plus fulvestrant, or everolimus plus exemestane.
However, the guidance said: “Alpelisib plus fulvestrant is associated with toxicity that has substantially limited its use in the NHS.
“And that everolimus plus exemestane has low response rates and exemestane is less effective for ESR1-positive cancer, which is up to 50% of cancers in this population.”
Capivasertib was approved by the Medicines and Healthcare products Regulatory Agency in July 2024, but was initially not recommended by NICE in draft guidance, published in January 2025, owing to “uncertainties in the clinical evidence and economic model”.
However, in the latest guidance, NICE said: “When considering the condition’s severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources.”
Claire Rowney, chief executive of the charity Breast Cancer Now, said the decision would offer eligible patients “the hope of more precious time to do what matters most to them before the disease progresses”.
Rowney added: “It’s fantastic news that capivasertib will be made available on the NHS for patients in England, but we shouldn’t overlook the fact that its initial provisional rejection meant patients have faced unnecessary delays in accessing it. 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.”
Helen Knight, director of medicines evaluation at NICE, said: “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.”
Peter Johnson, national clinical director for cancer at NHS England, said: “This new combination treatment offers an additional option for some people whose breast cancer has progressed despite previous hormone therapy and who may benefit from a targeted approach.
“While it won’t be suitable for everyone, giving patients more time before more intensive therapies are required is an important part of our drive to personalise cancer care and improve quality of life for patients wherever possible.”
