The Medicines and Healthcare Products Regulatory Agency (MHRA) has today approved the use of capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer, which features one or more abnormal “PIK3CA”, “AKT1”, or “PTEN” genes and does not respond to other anti-hormonal-based therapies.

The active substance in capivasertib is part of a group of medicines known as AKT inhibitors. These inhibitors block the action of ATK kinases proteins, which are responsible for cancer cell growth and multiplication. By inhibiting these proteins, capivasertib can slow down the growth and spread of advanced breast cancer and help destroy cancer cells.

Capivasertib is administered in combination with fulvestrant, a hormonal therapy used for advanced breast cancer treatment. The recommended dosage of capivasertib is 400 mg taken orally twice a day for four days, followed by a three-day rest period, repeated in cycles.

The approval of capivasertib was supported by data from a clinical trial involving 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 patients with tumours containing abnormal PIK3CA, AKT1, or PTEN genes. Patients received either capivasertib or a placebo, both in combination with fulvestrant.

Results from the clinical trial demonstrated that patients treated with capivasertib experienced an average of 7.3 months without cancer progression, compared to 3.1 months for those given a placebo.

Common side effects of capivasertib include high blood sugar, diarrhoea, rash and other skin reactions, urinary tract infections, low haemoglobin levels, loss of appetite, nausea, vomiting, mouth sores, itching, and tiredness.