Xtandi

enzalutamide

Table of contents

Opinion

On 25 March 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xtandi. The marketing authorisation holder for this medicinal product is Astellas Pharma Europe B.V..

The CHMP adopted an extension to the existing indication as follows:1

Xtandi is indicated for:

  • the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

 

1 New text in bold

Key facts

Name
Xtandi
Agency product number
EMEA/H/C/002639
International non-proprietary name (INN) or common name
  • enzalutamide
Active substance
  • enzalutamide
Therapeutic area
Prostatic Neoplasms
Date opinion adopted
25/03/2021
Company name
Astellas Pharma Europe B.V.
Status
Positive
Application type
Post-authorisation

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