20 November 2017 - Oral, once-daily medication Zytiga (abiraterone acetate) plus prednisone/prednisolone now approved in newly diagnosed high-risk metastatic hormone-sensitive prostate cancer.

Janssen today announced that the European Commission has granted approval to broaden the existing marketing authorisation for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. Abiraterone acetate plus prednisone prednisolone can now be used for the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)

The EC’s decision follows a recommendation from the CHMP that was based on data from the multinational, multicentre, randomised, double-blind, placebo-controlled Phase 3 study, LATITUDE. The trial was designed to determine if newly diagnosed patients with metastatic prostate cancer, who are naïve to castration and have high-risk prognostic factors, would benefit from the addition of abiraterone acetate and prednisone to androgen deprivation therapy vs ADT alone. Data were presented at the 2017 American Society of Clinical Oncology congress in Chicago, USA and published in the New England Journal of Medicine.

Read Janssen press release