EMA Recommends Extension of Indications for Enzalutamide

On 25 March 2021, the European Medicines Agency’s (EMA’s) 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 enzalutamide (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 (new text in bold):

Xtandi is indicated for:

  • the treatment of adult men with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT).
  • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
  • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated.
  • 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, which will be published in the revised European public assessment report, 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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