MHRA approves capivasertib for treatment of advanced breast cancer

The Medicines and Healthcare products Agency (MHRA) has authorised the use of a new drug for the treatment of locally advanced or metastatic HR-positive, HER 2-negative breast cancer.

Capivasertib (Truqap; AstraZeneca), an AKT inhibitor, works by blocking the effects of proteins called AKT kinases, which enable cancer cell growth and multiplication.

In an announcement, published on 17 July 2024, the UK regulator said the approval was supported by evidence from a clinical trial which found that patients treated with capivasertib experienced an average 7.3 months without cancer progression, compared to 3.1 months on placebo.

Results from the phase III randomised trial of 703 patients, published 31 May 2023 on The New England Journal of Medicine, also showed that the median time to deterioration from baseline was 24.9 months in the capivasertib group, compared with 12.0 months in the placebo group.

Capivasertib is an oral pill given with fulvestrant, a hormonal therapy, as an alternative treatment to endocrine-based regimens, which are recommended as the first-line treatment for most patients by the National Institute for Health and Care Excellence (NICE).

Potential side effects of capivasertib include high blood sugar, diarrhoea, rash and other skin drug reactions, urinary tract infection, low level of haemoglobin in blood, loss of appetite, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching and tiredness.

Commenting on the authorisation, Melanie Sturtevant, associate director of policy, evidence and influencing at charity Breast Cancer Now, said: “The MHRA’s welcome approval of capivasertib with fulvestrant is an important step towards this new effective treatment reaching patients.

“Crucially, compared to being treated with fulvestrant alone, capivasertib could offer people an additional four months before their disease progresses to continue doing the things they love and make memories.

“It’s vital that people with incurable secondary breast cancer can access treatments they need when they need them. As such, we hope that [NICE] appraisals for capivasertib progress quickly and smoothly so that it becomes available on the NHS as soon as possible for patients across the UK who could benefit.

Data show that breast cancer is the most common type of cancer in the UK, accounting for 15% of all new cases.

Latest data from Cancer Research UK shows an average of 56,822 new cases of breast cancer each year, with around 11,500 breast cancer deaths per year.

In November 2023, the MHRA extended the licence of anastrozole, an aromatase inhibitor, as a preventative option for post-menopausal women at moderate- or high-risk of breast cancer.

The decision was made as part of the ‘Medicines repurposing’ programme, which was launched by NHS England in March 2021 to identify and facilitate new use of medicines that are outside of their existing licences.

Final NICE guidance on capivasertib is scheduled to be published on 5 March 2025.