EMA Adopts a Positive Opinion for a New Indication for Enzalutamide

Concerns the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not yet indicated

On 23 October 2014, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation 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. They may request a re examination of the CHMP opinion, provided that they notify the EMA in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a new indication as follows:

"Xtandi is indicated for 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".

Detailed conditions 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 the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indications for enzalutamide will be as follows:

  • 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
  • the treatment of adult men with metastatic castration resistant prostate cancer whose disease has progressed on or after docetaxel therapy.