EMA Recommends Extension of Indications for Abiraterone Acetate

New indication concerns the treatment with prednisone or prednisolone in newly diagnosed high risk metastatic hormone sensitive prostate cancer in combination with ADT

On 12 October 2017, 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 abiraterone acetate (Zytiga).

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

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

Zytiga is indicated with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

Zytiga is from previously indicated for:

  • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
  • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

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.