European Commission approves Zytiga for the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer

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 Committee for Medical Products for Human Use (CHMP) that was based on data from the multinational, multicentre, randomised, double-blind, placebo-controlled Phase III 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 (ADT) 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.

See- "Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer"- Karim Fizazi, M.D., Ph.D., NamPhuong Tran, M.D., Luis Fein, M.D., Nobuaki Matsubara, M.D.,et al.,, for the LATITUDE Investigators- N Engl J Med 2017; 377:352-360July 27, 2017DOI: 10.1056/NEJMoa1704174.