Truqap

Truqap can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer treatments.

Truqap is available as tablets to be taken twice a day, approximately 12 hours apart. The tablets are taken for four consecutive days, followed by three days with no treatment. Fulvestrant is given on days 1, 15 and 29, and once monthly thereafter.

Treatment with Truqap should continue for as long as the patient benefits from it; treatment may be stopped, or the dose reduced, if the patient has unacceptable side effects.

For more information about using Truqap, see the package leaflet or contact your doctor or pharmacist.

The active substance in Truqap, capivasertib, blocks the activity of enzymes known as serine/threonine kinase (AKT) 1, 2 and 3. These enzymes play an important role in the growth and division of cancer cells with mutations in the PIK3CA, AKT1 or PTEN genes. By blocking AKT1, AKT2 and AKT3, Truqap reduces the growth of cancer cells.

Truqap, used together with fulvestrant, was shown to slow down the growth and spread of breast cancer in one main study involving 708 adults with locally advanced or metastatic ER‑positive and HER2‑negative breast cancer whose disease came back or got worse after treatment with an aromatase inhibitor (a medicine that reduces oestrogen levels).

Patients received either Truqap or placebo (a dummy treatment) in combination with fulvestrant and the main measure of effectiveness was how long patients lived without the disease getting worse. In nearly half of the patients, the cancer cells had one or more PIK3CA, AKT1 or PTEN mutations.

The study showed that in the group of patients with PIK3CA, AKT1 or PTEN mutations, those treated with Truqap plus fulvestrant lived on average for 7.3 months without the disease getting worse, compared with 3.1 months for patients given placebo plus fulvestrant.

For the full list of side effects and restrictions with Truqap, see the package leaflet.

The most common side effects with Truqap (which may affect more than 1 in 10 people) include diarrhoea, rash, nausea (feeling sick), tiredness, vomiting, stomatitis (inflammation of the lining of the mouth), hyperglycaemia (high blood glucose levels), headache and decreased appetite.

The most common severe side effects were rash, diarrhoea, hyperglycaemia, hypokalaemia (low blood potassium levels), anaemia (low levels of red blood cells) and stomatitis.

Truqap, used together with fulvestrant, was shown to slow down the growth and spread of breast cancer in adults with locally advanced or metastatic ER-positive and HER2-negative breast cancer with one or more PIK3CA, AKT1 or PTEN mutations.

Although patients treated with Truqap had more side effects than patients on placebo, the safety of Truqap in combination with fulvestrant was considered acceptable and manageable with standard care and dose modifications.

The European Medicines Agency therefore decided that Truqap’s benefits are greater than its risks and that it can be authorised for use in the EU.

The company that markets Truqap will conduct and submit the results of additional studies to further investigate the safety and effectiveness of the medicine, including in pre-menopausal women and in patients with diabetes, as the main study did not include patients with uncontrolled or insulin-dependent diabetes.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truqap have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Truqap are continuously monitored. Suspected side effects reported with Truqap are carefully evaluated and any necessary action taken to protect patients.

Truqap received a marketing authorisation valid throughout the EU on 17 June 2024.