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EMA Recommends Extension of Therapeutic Indications for Apalutamide

New indication concerns the treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy
17 Dec 2019
Anticancer agents & Biologic therapy;  Genitourinary cancers

On 12 December 2019, 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 apalutamide (Erleada).

The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.

The CHMP adopted an extension to the existing indication as follows (new text in bold):

Erleada is indicated:

  • in adult men for the treatment of non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.
  • in adult men for the treatment of metastatic hormone-sensitive prostate cancer in combination with androgen deprivation 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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