Xtandi

RSS

enzalutamide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 25/01/2019

Authorisation details

Product details
Name
Xtandi
Agency product number
EMEA/H/C/002639
Active substance
enzalutamide
International non-proprietary name (INN) or common name
enzalutamide
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BB04
Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
21/06/2013
Contact address

Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

23/10/2018 Xtandi - EMEA/H/C/002639 - II/0039/G

Contents

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Pharmacotherapeutic group

ENDOCRINE THERAPY

Therapeutic indication

Xtandi is indicated for:

•         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 castration-resistant prostate cancer 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 castration resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Assessment history

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