FDA issues Complete Response Letter to Amgen’s sBLA for XGEVA

[News]

Amgen today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for XGEVA (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

More... (http://www.news-medical.net/news/20120427/FDA-issues-Complete-Response-Letter-to-Amgene28099s-sBLA-for-XGEVA.aspx)