What you Need to Know About Denosumab (Xgeva)

Xgeva is used in men with advanced and metastatic prostate cancer with bone metastases for the prevention of developing additional skeletal-related events (not to be confused with bone mineral density). In a phase 3 trial, the 147 Study, evaluating denosumab (Xgeva) versus placebo 1,432 men with castrate-resistant prostate cancer demonstrated that Xgeva improved median bone [...]

Denosumab for the Prevention of Skeletal Events in Men with Castration-Resistant Advanced Prostate Cancer

From: the 2014 ASCO GU Meeting Abstract No: 35 Researchers have found in a randomized controlled trial of men with metastatic castration-resistant prostate cancer (mCRPC) the use of the treatment denosumab was superior to the more commonly used zoledronic acid (ZA) for reducing skeletal-related events (SRE). SREs are defined as a pathological fracture, surgery or [...]

Zoledronic Acid (ZA) in Castrate Sensitive Prostate Cancer Does Not Prove To Be Advantageous

One thing I have noticed at some of the support groups I run is that there seems to be a very uneven distribution of when men start taking Zoledronic Acid (ZA). Hormone therapy (ADT) has many negative side effects and the loss of bone mineral density (thinning of the bones) that ZA (and similar drugs) [...]

Early Use of Zoledronic Acid (Zometa) in Men with Castration-Sensitive Prostate Cancer and Bone Metastases: Results of CALGB 90202 (Alliance).

We have long known that Zoledronic Acid (Zometa) decreases a man’s risk of developing skeletal-related events (SREs) in men with castration-resistant advanced prostate cancer (CRPC) and bone metastases. In a phase III study that evaluated efficacy and safety of earlier treatment with Zometa in men with advanced prostate cancer which is still castration-sensitive found that [...]

From ASCO 2013 – Updated Analysis of radium-223 dichloride (Ra-223) impact on skeletal-related events (SRE) from the phase III randomized trial (ALSYMPCA).

Ra-223 (Alpharadin)is an alpha-pharmaceutical targeting bone metastases (mets) with high-energy, short-range (< 100 ?m) alpha-particles. Currently it has been submitted to the FDA for approval, which we hope will happen by August 2013. In the phase 3, double-blind, randomized, multinational ALSYMPCA study, Ra-223 significantly improved overall survival (OS) in men with castrate resistant advanced prostate [...]

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 [...]