This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 17/06/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

24/05/2022 Xtandi - EMEA/H/C/002639 - IB/0061

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Product information documents contain:

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.

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.

Assessment history

Changes since initial authorisation of medicine

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