FDA approval for breast cancer drug treatment developed at Velindre

11 December 2023

It all started more than 10 years ago with three people in a room in Cardiff, talking about ways to improve outcomes in the world’s most common type of cancer – oestrogen receptor positive breast cancer.

This led to the FAKTION clinical trial, investigating whether we could safely combine standard hormone therapy with AstraZeneca’s AKT inhibitor capivasertib, and did the combination improve patient outcomes.

The results from the Phase II trial showed that patients who received the combination treatment could expect to have their cancer controlled 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 now the USA’s Federal Drug Agency (FDA) has announced it will license the use of capivasertib, now called truqap, in combination with the hormone therapy drug faslodex for use in patients with ER positive, HER2 negative advanced breast cancer.

Professor Rob Jones, Co-Chief Investigator FAKTION trial and Associate Medical Director for RD&I at Velindre Cancer Centre, said:

"This is a big news story for Cardiff. It all started with the FAKTION trial which was developed at Velindre, sponsored by Velindre, and delivered in collaboration with Cardiff University’s Centre for Trials Research.

"Truqap is an international first-in-class drug for the use in patients with cancer and it’s the first license indication.

"The global impact of this research is immense - the group of patients who could receive this treatment represent about 75% of patients with metastatic breast cancer.

"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.

"There are still Europe and UK approvals needed before the drug can be used here but the future looks very encouraging for our patients.”

For more information about truqap and the FDA approval, visit AstraZeneca’s website.