Table of contents
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.
Xtandi : EPAR - Medicine overview (PDF/144.75 KB)
First published: 02/07/2013
Last updated: 12/05/2021
Xtandi : EPAR - Risk-management-plan summary (PDF/269.96 KB)
First published: 25/01/2019
Last updated: 12/05/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Astellas Pharma Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
24/05/2022 Xtandi - EMEA/H/C/002639 - IB/0061
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.