Xtandi

Treatment with Xtandi should be started and monitored by a doctor who has experience in treating prostate cancer.

Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription. The usual dose is 160 mg once a day, at about the same time each day. The doctor may have to reduce the dose or interrupt treatment if a patient gets certain side effects.

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

The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens. Enzalutamide does this by blocking the receptors to which these hormones attach. Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer.

Metastatic prostate cancer

Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel. In this study, Xtandi was more effective than placebo at prolonging patients’ lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo.

Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy. The average survival of patients treated with Xtandi was around 32 months compared with 30 months for patients treated with placebo. In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo.

Non-metastatic prostate cancer

Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic. Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo.

The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure). Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells). In addition, seizures (fits) can occur in around 4 patients in 1,000. For the full list of side effects with Xtandi, see the package leaflet.

Xtandi is not for use in women and must not be given to women who are or who may be pregnant. For the full list of restrictions, see the package leaflet.

The European Medicines Agency considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life for patients with metastatic disease is important for patients. Xtandi has also been shown to delay the development of metastatic disease. Regarding its safety, the side effects with Xtandi were generally mild and could be managed appropriately.

The Agency therefore concluded that Xtandi’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Xtandi will provide the results of an ongoing study on the long-term effects of Xtandi in men with non-metastatic prostate cancer.

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

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

Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.