In 2024, the Therapeutic Goods Administration (TGA) approved TRUQAP® (capivasertib), in combination with fulvestrant, for the treatment of eligible patients with HR+/HER2- locally advanced or metastatic breast cancer. As a condition of registration, the TGA mandated submission of all outstanding interim and final clinical study reports for this indication.
As a result of the TGA completing their evaluation of the additional data, the indication for TRUQAP has been updated. Previously no gene changes were required for patients to be eligible for TRUQAP. From today, only HR+ / HER2- locally advanced or metastatic breast cancer patients with changes in some of their genes (PIK3CA/AKT1/PTEN) are eligible for treatment: TRUQAP, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, following progression on at least one endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant therapy.
This indication update is based on additional clinical efficacy data and does not reflect any new safety concerns. It is consistent with the approved indication for TRUQAP in the United States and the European Union.
The TRUQAP Product Information includes updated safety data from the additional clinical evidence. These updates are consistent with the known safety profile of TRUQAP.
AstraZeneca has engaged with the Department of Health, including representatives from the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC), regarding the reimbursement pathway for the gene testing associated with the updated indication for TRUQAP. In the interim, patients may continue to access testing through established national services or private pathology providers.
Please click here to view consumer medicine information. PBS Information: Refer to the current PBS Schedule.
Safety: 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, urinary tract infection, anaemia, high potassium, decreased appetite. TRUQAP interacts with other medicines. Patients must discuss their treatment with their prescribing clinician.
TRUQAP® is a trademark of AstraZeneca. 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-26078 August 2026