Xtandi

enzalutamide

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This is a summary of the European public assessment report (EPAR) for Xtandi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xtandi.

For practical information about using Xtandi, patients should read the package leaflet or contact their doctor or pharmacist.

What is Xtandi and what is it used for?

Xtandi is a cancer medicine used to treat men with prostate cancer that has spread to other parts of the body and is castration resistant (i.e. worsens despite treatments that lower the production of testosterone or after surgical removal of the testes).

Xtandi is used in the following situations:

  • when treatment with docetaxel (a cancer medicine) has not worked or no longer works.
  • when hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not require chemotherapy (another type of cancer treatment).

The medicine contains the active substance enzalutamide.

How is Xtandi used?

Xtandi is available as capsules (40 mg) and can only be obtained with a prescription. The recommended dose is 160 mg (4 capsules) once a day with water. Treatment may have to be interrupted or the dose reduced if a patient experiences certain side effects. Xtandi should not be used together with certain medicines known as ‘strong CYP2C8 inhibitors’ that affect the way that Xtandi is eliminated by the body, or the dose of Xtandi should be reduced when used in combination. For further information, see the package leaflet.

How does Xtandi work?

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 and preventing them from responding. Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking these hormones, enzalutamide slows down the growth of the prostate cancer.

What benefits of Xtandi have been shown in studies?

Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with 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 18.4 months, compared with 13.6 months for patients given placebo.

Xtandi has also been compared with placebo in a second main study involving 1,717 patients with 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 32.4 months compared with 30.2 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: 19.7 months compared with 5.4 months for patients treated with placebo.

What are the risks associated with Xtandi?

The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, headache, hot flushes and hypertension (high blood pressure). Seizures (fits) occur in 4 patients in 1,000. For the full list of all side effects reported 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.

Why is Xtandi approved?

The Agency’s 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 anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life is important for patients. Regarding its safety, the Committee concluded that the side effects with Xtandi were generally mild and could be managed appropriately.

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

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 benefits from the second main study (as referred above) to further assess the benefits of Xtandi with respect to survival and how long patients lived without their disease getting worse.

Other information about Xtandi

The European Commission granted a marketing authorisation valid throughout the European Union for Xtandi on 21 June 2013. 

For more information about treatment with Xtandi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Xtandi : EPAR - Summary for the public BG = bălgarski 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public ES = español 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public CS = čeština 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public DA = dansk 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public DE = Deutsch 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public ET = eesti keel 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public EL = elliniká 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public EN = English 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public FR = français 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public IT = italiano 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public LV = latviešu valoda 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public LT = lietuvių kalba 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public HU = magyar 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public MT = Malti 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public NL = Nederlands 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public PL = polski 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public PT = português 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public RO = română 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public SK = slovenčina 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public SL = slovenščina 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public FI = suomi 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public SV = svenska 02/07/2013 20/01/2015
Xtandi : EPAR - Summary for the public HR = Hrvatski 02/07/2013 20/01/2015

This EPAR was last updated on 20/01/2015 .

Authorisation details

Product details

Product details for Xtandi
NameXtandi
Agency product numberEMEA/H/C/002639
Active substance

enzalutamide

International non-proprietary name (INN) or common name

enzalutamide

Therapeutic area Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Xtandi
Marketing-authorisation holder

Astellas Pharma Europe B.V.

Revision3
Date of issue of marketing authorisation valid throughout the European Union21/06/2013

Contact address:

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

Product information

28/11/2014  Xtandi -EMEA/H/C/002639 -II/0008

Name Language First published Last updated
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015
Xtandi : EPAR - Product Information HR = Hrvatski 02/07/2013 20/01/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  
Xtandi : EPAR - All Authorised presentations HR = Hrvatski 02/07/2013  

Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Treatment of adult men with metastatic castration‑resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Xtandi-H-C-2639-II-08 : EPAR - Assessment Report - Variation HR = Hrvatski 20/01/2015  
Xtandi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 30/10/2014 20/01/2015
CHMP post-authorisation summary of positive opinion for Xtandi HR = Hrvatski 24/10/2014  

Initial marketing-authorisation documents

Name Language First published Last updated
Xtandi : EPAR - Public assessment report HR = Hrvatski 02/07/2013  
CHMP summary of positive opinion for Xtandi HR = Hrvatski 26/04/2013  

Authorised

This medicine is approved for use in the European Union