Velindre research leads to NICE approved treatment for NHS breast cancer patients

14 April 2025

NICE (National Institute for Health and Care Excellence) has announced today that a treatment for advanced breast cancer that started its life in Cardiff more than 10 years ago, has been approved for use by the NHS in England and Wales.

“It is fantastic news that the results of the FAKTION trial have now resulted in NICE approval, meaning that British breast cancer patients will now beable gain access to capivasertib through the NHS,” said Professor Rob Jones, Co-Chief Investigator FAKTION trial and Associate Medical Director for RD&I at Velindre Cancer Centre

“FAKTION was led from Cardiff and showed that patients with cancer containing one or more of three biomarkers could expect to double their life span if capivasertib was added to their hormone therapy.

“These findings were then confirmed in a larger Phase 3 trial and the results from both trials have been crucial in gaining the NICE approval.

“When a patient has been diagnosed with metastatic cancer, patients are often most concerned about how much time they have left. While we're not able to offer a cure, this new medicine will buy people additional really important time they can spend with their families and friends.”

The Phase I  FAKTION clinical trial sponsored by Velindre began in 2014 and the results showed that we could safely combine standard hormone therapy with AstraZeneca’s AKT inhibitor capivasertib.

The next step was a Phase II trial which closed in 2018, that showed that patients who received the combination treatment could expect to have their cancer controlled and live for twice as long as those receiving hormone therapy alone.

AstraZeneca were excited by the FAKTION trial results and started a Phase III global trial which confirmed the FAKTION findings and led to the USA’s Federal Drug Agency (FDA) licensing the drug treatment for use in patients with ER positive, HER2 negative advanced breast cancer in June 2023.

Approvals followed in 2024 from the European Medical Agency and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), with NICE approval needed to enable NHS patients to receive the treatment.