Eligible Australians living with metastatic breast cancer1 can access AstraZeneca’s TRUQAP® (capivasertib) on the Pharmaceutical Benefits Scheme (PBS) from 1 October 2025.
The PBS listing of TRUQAP® is for the treatment, in combination with fulvestrant, of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy.2
TRUQAP® contains the active ingredient capivasertib and belongs to a class of medicines known as AKT inhibitors. It works by blocking the effects of AKT kinases – proteins that are often overactive in cancer cells and help them to grow and multiply2. TRUQAP® in combination with fulvestrant can reduce the growth and spread of cancer and help to destroy cancer cells.2
· Of the 21,000 Australians diagnosed with breast cancer each year, approximately 22 per cent progress to metastatic (advanced or late stage) disease within 14 years3 and around 1,000 have metastatic breast cancer at first diagnosis.4
· Metastatic breast cancer is an invasive cancer that has spread to other parts of the body, such as the bones, lungs, liver or brain5. Currently there are no cures.6
· Affecting approximately 7,900 people in New South Wales7, 3,863 in Queensland8 and 4,461 in Victoria9 alone, metastatic breast cancer requires ongoing treatment, with the aim to slow disease progression and maintain a patient’s quality of life.10
· HR-positive, HER2-negative breast cancer accounts for 70 per cent of cases11, and people with this subtype may develop resistance to endocrine therapies, leaving them with limited treatment options.12
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered innovative breast cancer medicines to Australian patients for more than 40 years, welcomed the latest PBS listing.
“Up to 3,000 Australian patients may now be able to access TRUQAP® on the PBS each year,” Mr 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.
“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,” Mr McDonald said.
Professor Fran Boyle is a Medical Oncologist at The Mater Hospital in North Sydney who treats patients with metastatic breast cancer. She said: “Survival outcomes for patients with metastatic breast cancer have improved significantly over the past 20 years13, but still only one-third of patients are alive five years after their diagnosis.14
“The addition of TRUQAP® to the PBS means there is a new treatment option that can be used before chemotherapy, if this is desired.”
Dr Andrea Smith, a founding member of MBC Action Australia, a national, consumer-led advocacy organisation for people with metastatic breast cancer, said the PBS listing was welcome news.
“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.”
ABOUT TRUQAP®2
Indication: TRUQAP® is used in combination with fulvestrant to treat patients with HR-positive, HER2-negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy.
Precautions: Patients should inform their doctor if they have any of the following medical conditions: have or have ever had high levels of sugar in your blood or diabetes; any current infections; diarrhoea or loose stools; rash or other skin disorders; kidney problems or high levels of creatinine or uric acid in your blood; liver problems; and/or allergies to other medicines, foods, preservatives or dyes. TRUQAP® should not be used in those pregnant, breastfeeding, or planning to become pregnant. Refer to the full CMI for more information on contraception.
Interactions: Patients should inform their doctor if they are taking any other medicines, including any antibiotics to treat bacterial infections; medicines to treat fungal infections; medicines for epilepsy; medicines to treat high blood pressure in the lungs; medicines to treat high cholesterol; medicines to suppress the immune system; medicines to treat cancer; anti-viral medicines and/or St John’s Wort for depression. Patients should also avoid drinking large amounts of grapefruit juice while taking TRUQAP® as it may increase the side effects.
Side Effects: All medicines can have side effects, most of which are minor and temporary. These include nausea, vomiting, tiredness, mouth sores or ulcers. However, some serious side effects may need medical attention. These can include diarrhoea, high blood sugar levels, severe blistering, peeling or scaling of skin or skin reactions.
More information can be found in the TRUQAP® Consumer Medicine Information here: https://medsinfo.com.au/consumer-information/document/Truqap_CMI?drug_id=19212&documenttype=cmi
This medicine is new or being used differently. Please report side effects. See the full CMI for further details.
PBS Information15:
Authority Required. Refer to PBS Schedule for full Authority Required Information.
- ENDS-
Professor Fran Boyle has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Boyle, and the opinions expressed are their own. Professor Boyle has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
TRUQAP® is a trademark of AstraZeneca. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
Notes to editors
Breast cancer in Australia
Breast cancer is the most commonly diagnosed cancer among women in Australia. Approximately 58 Australians are diagnosed each day, equating to over 21,000 Australians each year.14
1 in 7 women and 1 in 550 men are diagnosed with breast cancer in their lifetime.14
On average, nine Australians die from breast cancer every day, or 3,330 people each year.14
About TRUQAP®2
TRUQAP® contains the active ingredient capivasertib. It belongs to a group of medicines called AKT inhibitors and works by blocking the effects of proteins called AKT kinases, which help cancer cells to grow and multiply.
TRUQAP® is prescribed and administered to patients orally. Two 200 mg tablets are taken orally approximately 12 hours apart (total daily dose of 800 mg) for four days, followed by three days off treatment.
TRUQAP® is used in combination with fulvestrant, which is given as an injection administered by a healthcare professional. The recommended dose of fulvestrant is 500mg, administered on Days 1, 15, and 29, and once monthly thereafter.
In pre/peri-menopausal women, TRUQAP® plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist, according to current clinical practice standards.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com.au
References
1. Huppert et al. Systemic therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative early stage and metastatic breast cancer. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21777 Accessed September 2025
2. TRUQAP CMI. www.medsinfo.com.au/consumer-information/document/Truqap_CMI?drug_id=19212&documenttype=cmi Accessed September 2025
3. Lord et al. Long-term risk of distant metastasis in women with non-metastatic breast cancer and survival after metastasis detection: a population-based linked health records study. MJA 217 (8) 402-409 (2022) https://onlinelibrary.wiley.com/doi/10.5694/mja2.51687 Accessed September 2025
4. Australian Government, Cancer Australia. 2019. Top 10 best practices for people with metastatic breast cancer. Available at: https://www.canceraustralia.gov.au/about-us/news/top-10-best-practices-people-metastatic-breast-cancer Accessed August 2024
5. Breast Cancer Network Australia. 2023. What is metastatic breast cancer? Available at: https://www.bcna.org.au/metastatic-breast-cancer/what-is-metastatic-breast-cancer/ Accessed 2 August 2024
6. BreastCancer.org. 2023. Myths and Misconceptions About Metastatic Breast Cancer. Available at: https://www.breastcancer.org/types/metastatic/myths Accessed 2 August 2024
7. NSW first in world to identify the number of people living with mBC. www.health.nsw.gov.au/news/Pages/20241016_01.aspx
Accessed Sep 2025
8. Landmark step for women with mBC in Queensland www.bcna.org.au/latest-news/bcna-news/landmark-step-for-women-with-metastatic-breast-cancer-in-queensland/ accessed Sep 2025
9. Finally counted: A milestone for Victorians living with metastatic breast cancer, www.bcna.org.au/latest-news/bcna-news/finally-counted-a-milestone-for-victorians-living-with-metastatic-breast-cancer/#:~:text=For%20the%20first%20time%2C%20Victoria%20has%20counted%20everyone,major%20step%20forward%20for%20visibility%2C%20recognition%2C%20and%20support. accessed Sep 2025
10. Breast Cancer Network Australia. 2022. Making Metastatic Breast Cancer Count. Available at: https://www.bcna.org.au/latest-news/bcna-news/making-metastatic-breast-cancer-count/ Accessed September 2025
11. Fasching et al Identification of Patients with Early HR+ HER2- Breast Cancer At High Risk of Recurrence www.pmc.ncbi.nlm.nih.gov/articles/PMC10853032/ Accessed September 2025
12. Mazumder et al HER2 Activation and Endocrine Treatment Resistance in Her2-negative breast cancer www.pmc.ncbi.nlm.nih.gov/articles/PMC8379900/ Accessed September 2025
13. Miglietta et al. Major advancements in metastatic breast cancer treatment: when expanding options means prolonging survival. ESMO Open 2022. Available at: https://www.esmoopen.com/article/S2059-7029(22)00030-8/fulltext Accessed September 2025
14. National Breast Cancer Foundation. 2021. Breast Cancer Stats. Available at: https://nbcf.org.au/about-breast-cancer/breast-cancer-stats Accessed September 2025
15. TRUQAP Product Information. www.tga.gov.au/sites/default/files/2025-02/auspar-truqap-pi-250130.pdf Accessed September 2025
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-23454 September 2025