Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for Zytiga® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications.
If approved by the European Commission, abiraterone acetate plus prednisone / prednisolone in combination with androgen deprivation therapy (ADT) can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).1
“As shown by the results from the LATITUDE study, adding abiraterone acetate plus prednisone / prednisolone to ADT alone significantly improves overall survival and radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer and high-risk features in comparison to treating patients with ADT alone, where median survival is currently less than three years. Today’s decision means we are one step forward in ensuring mHSPC men across Europe may be able to benefit from this treatment soon,” said Professor Karim Fizazi, principal investigator of the LATITUDE trial and Head of the Medical Oncology Department at Institute Gustave Roussy.
The CHMP recommendation is 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 mHNPC who have high-risk prognostic factors benefit from the addition of abiraterone acetate and prednisone to androgen deprivation therapy (ADT) vs placebos and ADT.2 Data were presented at the 2017 American Society of Clinical Oncology congress in Chicago, USA and published in the New England Journal of Medicine.
- European Medicines Agency. ZYTIGA CHMP meeting highlights. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/…. Last accessed October 2017
- National Institutes of Health. A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC). Available at: https://clinicaltrials.gov/show/NCT01715285. Last accessed October 2017.