TRUQAP

What it is

TRUQAP is available as film-coated tablets containing either 160 mg or 200 mg of capivasertib. Capivasertib is an inhibitor of the kinase activity of all three isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3). This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications

— Treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (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 an endocrine-based regimen, in combination with fulvestrant.

Dosing overview

The recommended dose of TRUQAP in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily approximately 12 hours apart (total daily dose of 800 mg) with or without food, for four days followed by three days off treatment. 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; for men, consider administering a LHRH agonist according to current clinical practice standards.

Key safety warnings

Severe hyperglycaemia has occurred in 8 (2.3%) patients treated with TRUQAP, with severe hyperglycaemia associated with diabetic ketoacidosis (DKA) and ketoacidosis reported in patients treated with TRUQAP, including cases with fatal outcomes. DKA can occur at any time during TRUQAP treatment, and in some reported cases it developed in less than ten days. Before initiating treatment with TRUQAP, inform patients about TRUQAP's potential to cause hyperglycaemia and request that they immediately contact their healthcare professional if hyperglycaemia symptoms (such as excessive thirst, urinating more often than usual or greater amounts of urine than usual, or increased appetite with weight loss) occur. Patients must be tested for fasting blood glucose levels and HbA1C prior to start of treatment with TRUQAP and in accordance with recommended intervals. Severe diarrhoea associated with dehydration was observed in patients treated with TRUQAP, with acute kidney injury reported in association with dehydration, and diarrhoea has been frequently reported in patients treated with TRUQAP. Advise patients to start anti-diarrhoeal treatment at the first sign of diarrhoea and increase oral fluids if diarrhoea symptoms occur while taking TRUQAP; maintenance of normovolaemia and electrolyte balance is required in patients with diarrhoea to avoid complications related to hypovolaemia and low electrolyte levels. Skin reactions, including erythema multiforme and dermatitis exfoliative generalised, were reported in patients receiving TRUQAP; drug reaction with eosinophilia and systemic symptoms (DRESS) was reported in one patient treated with TRUQAP in CAPItello-291; and palmar-plantar erythrodysesthesia was reported in three patients treated with TRUQAP in CAPItello-291. Early consultation with a dermatologist is recommended to ensure greater diagnostic accuracy and appropriate management.

Contraindications

Prior severe hypersensitivity to the active substance or to any of the excipients.

PBS listing

Both the 160 mg and 200 mg tablet strengths are listed on the PBS with authority required restriction, at an ex-manufacturer price of A$8397.00.

Regulatory history

TRUQAP capivasertib 200 mg and 160 mg film-coated tablets were first registered on the ARTG on 9 May 2024. In November 2024, the PBAC recommended against listing the medicine, noting moderate clinical benefit in progression-free survival but no demonstrated improvement in overall survival, an inferior safety profile, and a high incremental cost-effectiveness ratio at the proposed price. In March 2025, the PBAC recommended the medicine for PBS listing for HR+/HER2− locally advanced (unresectable) or metastatic breast cancer with evidence of an AKT pathway alteration, following recurrence or progression on or after endocrine therapy.