Posted by Michael Wonder on 13 Oct 2017
CHMP issues a positive opinion on Janssen’s Zytiga to include earlier stage prostate cancer patients
13 October 2017 - CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer.
Janssen today announced that the EMA's 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).
“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.
