drugs

Xtandi - Enzalutamide

What is Xtandi - Enzalutamide and what is it used for?

Xtandi is an anticancer medicine used to treat male subjects with prostate cancer that has spread to other parts of the body and is resistant to castration (for example, it gets worse despite treatments that lower testosterone production or after surgical removal of the testicles). Xtandi is used in the following cases:

  • when treatment with docetaxel (an anticancer medicine) has not been effective or is no longer effective;
  • when hormone therapy has not worked and the patient reports no symptoms or mild symptoms and does not require chemotherapy (another type of anticancer treatment)

The drug contains the active ingredient enzalutamide .

How is Xtandi - Enzalutamide used?

Xtandi is available as a capsule (40 mg) and can only be obtained with a prescription. The recommended dose is 160 mg (4 capsules) once a day with water. It may be necessary to stop treatment or reduce the dose if patients experience certain side effects. Xtandi should not be used concomitantly with certain medicines known as "potent CYP2C8 inhibitors" that affect the way Xtandi is eliminated from the body, or else the dose of Xtandi should be reduced when used in combination with other medicines. For more information, see the package leaflet.

How does Xtandi - Enzalutamide work?

The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens. For this purpose, enzalutamide blocks the receptors to which these hormones bind and prevents their response. Since prostate cancer needs testosterone and other male hormones to survive and grow, blocking these hormones enzalutamide slows the growth of the said cancer.

What benefit has Xtandi - Enzalutamide shown during the studies?

Xtandi was compared with placebo (a dummy treatment) in a main study involving 199 patients with castration-resistant prostate cancer and previously treated with docetaxel. This study showed that Xtandi was more effective than placebo in prolonging patients' lives: on average, patients treated with Xtandi lived for 18.4 months compared to 13.6 months for patients who were given placebo. Xtandi has also been compared with placebo in a second main study involving 1 717 castration-resistant prostate cancer patients in whom hormone therapy had not been effective but had no symptoms or had mild or no symptoms. previously undergoing chemotherapy. The median survival times of patients treated with Xtandi were approximately 32.4 months compared to 30.2 months in placebo-treated patients. Furthermore, patients treated with Xtandi lived for a longer period of time without the disease showing signs of worsening on radiographic scan: 19.7 months versus 5.4 months for placebo-treated patients.

What is the risk associated with Xtandi - Enzalutamide?

The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, headache, hot flushes and high blood pressure (high blood pressure). Seizures have occurred in four of every 1 000 patients. For the full list of all side effects reported with Xtandi, see the package leaflet. Xtandi should not be used in women and should not be given to women who are or could be pregnant. For the full list of limitations, see the package leaflet.

Why has Xtandi - Enzalutamide been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Xtandi's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the antitumor effects of Xtandi have been clearly demonstrated and that the effect in terms of prolonging life is important for patients. Regarding safety, the committee concluded that the side effects of Xtandi are generally moderate and can be managed appropriately.

What measures are being taken to ensure the safe and effective use of Xtandi - Enzalutamide?

A risk management plan has been developed to ensure that Xtandi is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xtandi, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company will provide long-term data on the benefits of the second main study (as reported above) to further verify the benefits of Xtandi with respect to survival times and time spent by patients without worsening the disease.

Other information on Xtandi - Enzalutamide

On 21 June 2013, the European Commission issued a marketing authorization for Xtandi, valid throughout the European Union. For more information about treatment with Xtandi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.