The FDA Approves Abiraterone Acetate for Some Men with Castrate Sensitive Metastatic Prostate Cancer

The Food and Drug Administration approved the use of abiraterone acetate (Zytiga) with prednisone for men with high-risk, castration-sensitive, chemotherapy-naive metastatic prostate cancer, but there are some hitches and hurdles.

This approval expands the use of Zytiga to an earlier stage of the disease, to men who are still castrate sensitive, but who still must meet other criteria.  The potential issue surrounds the words, high-risk prostate cancer. 

What is high risk?  According to the criteria used by the LATITUDE trial and thus the FDA approval to be considered high-risk men will have to be:


1- Newly diagnosed with castration-sensitive metastatic prostate cancer, documented with a positive bone scan, CT or MRI,

2- Be at least 18 years old,

3- A ECOG performance score of 0, 1, or 2, and

4- Have two out of three of the following “high-risk” factors:


1a.  A Gleason score of ≥ 8

2b.  Have three or more lesions as evidenced on a bone scan

3c.  Evidence of visceral metastasis


This approval expands the use of Zytiga, but the expansion has significant limitations.


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.