AstraZeneca’s first-in-class therapy PBS listed in advanced breast cancer

From 1 October 2025, AstraZeneca’s first-in-class AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) will be available through the Pharmaceutical Benefits Scheme (PBS) for Australians living with HR-positive, HER2-negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy.

Each year, around 21,000 Australians are diagnosed with breast cancer. Of these, approximately 22% progress to metastatic disease within 14 years, and around 1,000 present with metastatic breast cancer at their first diagnosis. HR-positive, HER2-negative breast cancer accounts for 70% of cases. Patients with this subtype often develop resistance to endocrine therapy, leaving few effective treatment pathways.

Ben McDonald, Country President of AstraZeneca ANZ, described the PBS listing as a significant milestone.

“Up to 3,000 Australian patients may now be able to access Truqap on the PBS each year,” McDonald said. “AstraZeneca is investing in science and exploring new ways to diagnose and treat breast cancer so patients have targeted treatment options available to them.”

Professor Fran Boyle, Medical Oncologist at The Mater Hospital in North Sydney, said the decision provides a much-needed option for patients with advanced disease.

“Survival outcomes for patients with metastatic breast cancer have improved significantly over the past 20 years, but still only one-third of patients are alive five years after their diagnosis. The addition of Truqap to the PBS means there is a new treatment option that can be used before chemotherapy, if this is desired,” explained Professor Boyle.

Results from the CAPItello-291 clinical trial showed that Truqap combined with Faslodex reduced the risk of progression or death by 50% compared with Faslodex alone in previously treated HR+/HER2- breast cancer patients. The benefit was most pronounced in patients with AKT-related mutations, where progression-free survival improved by 50%. Importantly, the regimen also delivered a 21% improvement in progression-free survival among patients without AKT pathway alterations, according to exploratory analysis.

Dr Andrea Smith, a founding member of MBC Action Australia, said the decision will help ease the financial and emotional burden facing people with metastatic breast cancer.

“The estimated 24,000 people living with metastatic breast cancer in Australia often balance work and family responsibilities while dealing with the unrelenting psychological and physical demands of their diagnosis,” Dr Smith said. “Our growing community welcomes the Government’s reimbursement of Truqap as it will enable affordable access to another treatment option for those living with HR-positive, HER2-negative metastatic breast cancer.”

While overall survival data from CAPItello-291 remains immature, quality-of-life findings published in September 2024 showed meaningful benefit. Patients receiving the Truqap-Faslodex combination reported a median time to deterioration in global health status and quality of life of almost 25 months, double that seen in the Faslodex-only arm at 12 months.

Minister for Health, Ageing and Disability, Mark Butler MP, linked the announcement to broader efforts in cancer care.

“October is breast cancer awareness month, and the Government is ensuring new treatments are available to breast cancer patients at affordable PBS prices,” said Minister Butler.

McDonald reinforced AstraZeneca’s ongoing commitment to optimal patient care.

“We will continue to advocate for earlier diagnosis of disease, faster access to medicines and fairer access in a more equitable system for the benefit of all Australians facing breast cancer and those who love them,” he said.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.