Zytiga

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Questions & Answers

On 12 October 2017, 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 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:1

“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) (see section 5.1)
  • 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 (see section 5.1)
  • 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 (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.


1New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Zytiga (English only) 2017-10-13  

Key facts

Product details for Zytiga
NameZytiga
INN or common name

abiraterone

Therapeutic area Prostatic Neoplasms
Active substance

abiraterone acetate

Date opinion adopted12/10/2017
Company name

Janssen-Cilag International NV

StatusPositive
Application typePost authorisation