Overview

Xtandi is a cancer medicine used to treat men with prostate cancer.

It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:

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

Xtandi can also be used for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so.

The medicine contains the active substance enzalutamide.

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.

Xtandi : EPAR - Medicine overview

български (BG) (164.9 KB - PDF)
español (ES) (140.8 KB - PDF)
čeština (CS) (164.43 KB - PDF)
dansk (DA) (140.08 KB - PDF)
Deutsch (DE) (143.79 KB - PDF)
eesti keel (ET) (128.47 KB - PDF)
ελληνικά (EL) (165.11 KB - PDF)
français (FR) (141.93 KB - PDF)
hrvatski (HR) (163.49 KB - PDF)
italiano (IT) (132.72 KB - PDF)
latviešu valoda (LV) (170.2 KB - PDF)
lietuvių kalba (LT) (164.09 KB - PDF)
magyar (HU) (162.23 KB - PDF)
Malti (MT) (164.74 KB - PDF)
Nederlands (NL) (139.91 KB - PDF)
polski (PL) (165.13 KB - PDF)
português (PT) (141.19 KB - PDF)
română (RO) (160.49 KB - PDF)
slovenčina (SK) (164.75 KB - PDF)
slovenščina (SL) (161.64 KB - PDF)
Suomi (FI) (138.42 KB - PDF)
svenska (SV) (139.58 KB - PDF)

Xtandi : EPAR - Risk management plan

Product information

Xtandi : EPAR - Product Information

български (BG) (1.63 MB - PDF)
español (ES) (1.38 MB - PDF)
čeština (CS) (1.77 MB - PDF)
dansk (DA) (1.31 MB - PDF)
Deutsch (DE) (1.4 MB - PDF)
eesti keel (ET) (1.37 MB - PDF)
ελληνικά (EL) (1.41 MB - PDF)
français (FR) (1.58 MB - PDF)
hrvatski (HR) (2.04 MB - PDF)
íslenska (IS) (1.61 MB - PDF)
italiano (IT) (1.55 MB - PDF)
latviešu valoda (LV) (1.5 MB - PDF)
lietuvių kalba (LT) (1.53 MB - PDF)
magyar (HU) (1.38 MB - PDF)
Malti (MT) (1.53 MB - PDF)
Nederlands (NL) (1.6 MB - PDF)
norsk (NO) (1.55 MB - PDF)
polski (PL) (1.35 MB - PDF)
português (PT) (1.56 MB - PDF)
română (RO) (2.81 MB - PDF)
slovenčina (SK) (1.44 MB - PDF)
slovenščina (SL) (1.67 MB - PDF)
Suomi (FI) (1.82 MB - PDF)
svenska (SV) (1.45 MB - PDF)

Latest procedure affecting product information: IB/0061

24/05/2022

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Xtandi : EPAR - All Authorised presentations

български (BG) (41.17 KB - PDF)
español (ES) (18.49 KB - PDF)
čeština (CS) (39.76 KB - PDF)
dansk (DA) (18.31 KB - PDF)
Deutsch (DE) (18.1 KB - PDF)
eesti keel (ET) (18.4 KB - PDF)
ελληνικά (EL) (46.5 KB - PDF)
français (FR) (18.1 KB - PDF)
hrvatski (HR) (26.84 KB - PDF)
íslenska (IS) (18.28 KB - PDF)
italiano (IT) (23.24 KB - PDF)
latviešu valoda (LV) (39.76 KB - PDF)
lietuvių kalba (LT) (41.21 KB - PDF)
magyar (HU) (34.6 KB - PDF)
Malti (MT) (35.31 KB - PDF)
Nederlands (NL) (22.17 KB - PDF)
norsk (NO) (18.46 KB - PDF)
polski (PL) (42.73 KB - PDF)
português (PT) (19.7 KB - PDF)
română (RO) (35.95 KB - PDF)
slovenčina (SK) (28.89 KB - PDF)
slovenščina (SL) (28.2 KB - PDF)
Suomi (FI) (18.33 KB - PDF)
svenska (SV) (18.3 KB - PDF)

Product details

Name of medicine
Xtandi
Active substance
enzalutamide
International non-proprietary name (INN) or common name
enzalutamide
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BB04

Pharmacotherapeutic group

Endocrine therapy

Therapeutic indication

Xtandi is indicated for:

  • the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).
  • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
  • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
  • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

Authorisation details

EMA product number
EMEA/H/C/002639
Marketing authorisation holder
Astellas Pharma Europe B.V.

Sylviusweg 62
2333 BE Leiden
The Netherlands

Opinion adopted
25/04/2013
Marketing authorisation issued
21/06/2013
Revision
21

Assessment history

Xtandi : EPAR - Procedural steps taken and scientific information after authorisation

Xtandi-H-C-PSUSA-00010095-202008 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Xtandi-H-C-2639-II-0047-G : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Xtandi (II-47-G)

Xtandi-H-C-2639-II-0039-G : EPAR - Assessment Report - Variation

Xtandi-H-C-PSUSA-00010095-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Xtandi-H-C-2639-II-0008 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Xtandi

Xtandi : EPAR - Public assessment report

CHMP summary of positive opinion for Xtandi

Topics

This page was last updated on

How useful do you find this page?