Zytiga’s Label is Expanded To Include Men with Hormone Sensitive Prostate Cancer in the European Union

Zytiga (abiraterone acetate) plus prednisone along with hormone therapy (ADT) has just received the go-ahead in the EU for use in men with who are newly diagnosed with castrate sensitive prostate cancer (mHSPC).

This label change in the EU moves the approved use of Zytiga to earlier stages of prostate cancer.  Under this change, men who are diagnosed with metastatic prostate cancer can qualify to receive Zytiga despite never having failed ADT.

Prior to this label change Zytiga was approved in combination with prednisone for the treatment of metastatic castration-resistance prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failing ADT and in men where chemotherapy is not yet clinically indicated as well as in men whose disease had progressed on or after a docetaxel-based chemotherapy regimen.

This approval has already been made in the United States.  The change has been long awaited given that early use of Zytiga has shown to offer a significant survival advantage to newly diagnosed men with metastatic disease.

Joel T. Nowak, MA, MSW wrote this Post.  Joel is the CEO/Executive Director of Cancer ABCs.  He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.