A Goal Date for the Possible FDA Approval of Xgeva® (Denosumab) for men with Advanced Prostate Cancer

Amgen (NASDAQ: AMGN) today published a press release that said the U.S. Food and Drug Administration (FDA) will target an action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) (approval) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer with the goal of reducing the risk [...]

Timely Use of Zoledronic Acid Provides Both Longer Hospital Free Survival and Increased Survival

A recent study conducted at the Southeast Louisiana Veterans Health Care System, New Orleans, LA, USA by the Section of Hematology and Medical Oncology, Tulane University School of Medicine, New Orleans, LA, evaluated the efficacy of the timely use of zoledronic acid (ZA) on clinical outcomes and health care utilization in men with bone-metastatic prostate [...]

Xgeya (denosumb) Approved To Protect Bones In Men With Metastatic Prostate Cancer

This has been an interesting year as men with advanced prostate cancer have seen three different drugs approved. Considering that the prior six years did not have any new drug approvals, this has been a stellar year. First we had Provenge approved, then came Jevtana and now we have added to the list Xgeya (denosumb). [...]

Denosumab Demonstrates An Increased Time to First Skeletal Event in Men with Metastatic Prostate Cancer vs Zometa

In men with bone metastasis from castration-resistant prostate cancer (CRPC), a monthly subcutaneous injection with denosumab, 120 mg, is superior to Zometa, a multinational group of researchers reported at the American Society of Clinical Oncology annual meeting. The current standard of care is for men with bone metastasis from castration-resistant prostate cancer (CRPC) is to [...]

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