The European Commission (EC) has agreed to broaden Janssen's existing marketing authorisation for Zytiga, the Belgium-based pharmaceutical company said on Tuesday.
Janssen, a Johnson and Johnson (NYSE: JNJ) company, stated that the licence for Zytiga (abiraterone acetate) plus prednisone/prednisolone will be widened to include an earlier stage of metastatic prostate cancer than its current indications.
Thanks to the approval, abiraterone acetate plus prednisone/prednisolone is now indicated for the treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
"This EC approval is a major step forward for men living with prostate cancer across Europe and offers patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer a new treatment option," said Dr Ivo Winiger-Candolfi, oncology solid tumour therapy area lead for Janssen Europe, Middle East and Africa.
"We are encouraged by the data we have seen to date and remain committed to transforming outcomes for prostate cancer patients."
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