Posted on September 3, 2014 by Sitemaster
Denosumab — marketed as Xgeva and as Prolia — is associated with a rare but well-known risk for severe hypocalcemia (very low calcium in the blood stream). Denosumab, when give as Xgeva, is specifically indicated for the prevention of skeletal-related events in patients with bone metastases from prostate and other forms of cancer. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, hypocalcemia, risk, side effect, vitamin D | 1 Comment »
Posted on August 17, 2012 by Sitemaster
In issuing final draft guidance on the coverage of treatment with denosumab (Xgeva) for patients with metastases to the bones, the National Institute for Clinical Excellence (NICE) in England again has excluded men with prostate cancer-induced metastases to bone. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: bone, denosumab, metastasis, NICE, Xgeva | 15 Comments »
Posted on June 13, 2012 by Sitemaster
In the UK, the National Institute for Clinical Excellence has announced revisions to its initial, draft recommendation on the clinical use of denosumab (Xgeva®) for the treatment of people with cancer that has metastasized to the bones. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, NICE, skeletal-related events, Xgeva | Leave a comment »
Posted on April 27, 2012 by Sitemaster
According to a Reuters report issued late last night, the U.S. Food and Drug Administration (FDA) has rejected an application by Amgen to market denosumab (Xgeva®) as a treatment to delay the onset of bone metastases in men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …
Filed under: Management, Treatment | Tagged: castration-resistant, CRPC, denosumab, non-metastatic | 1 Comment »
Posted on February 8, 2012 by Sitemaster
According to an online report in The Washington Post earlier this afternoon, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted 12 to 1 not to recommend the approval of denosumab (Xgeva®) for the prevention of bone metastasis in men with non-metastatic, castrate-resistant prostate cancer. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, metastasis, Prevention, Xgeva | Leave a comment »
Posted on February 6, 2012 by Sitemaster
The U.S. Food and Drug Administration (FDA) has questioned the value of denosumab (Xgeva®) as an agent capable of delaying the onset of metastatic disease to bone in men with progressive, castration-resistant prostate cancer. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: bone, denosumab, metastasis, Prevention, Xgeva | 7 Comments »
Posted on November 17, 2011 by Sitemaster
The full data on the use of denosumab to delay the onset of bone metastasis in men with high-risk, progressive, non-metastatic, castration-resistant prostate cancer (CRPC) were published on line yesterday in The Lancet. We originally reported the results of this trial as presented at the annual meeting of the American Urological Association (AUA) in May this year. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, metastasis, Prevention, survival | Leave a comment »
Posted on September 19, 2011 by Sitemaster
According to a media release issued by Amgen earlier today, the U.S. Food & Drug Administration (FDA) has approved denosumab (marketed as both Prolia® and Xgeva®) as a treatment to increase bone mass in in men with non-metastatic prostate cancer who are already being treated with androgen deprivation therapy (ADT) and who are at high risk for bone fractures. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Prevention, Treatment | Tagged: approval, denosumab, fracture, Prevention | Leave a comment »
Posted on August 22, 2011 by Sitemaster
According to a media release from Amgen earlier today, the U.S. Food & Drug Administration (FDA) has indicated that a decision will be made by April 26, 2012 about the requested expansion of the indication for denosumab (Xgeva®) to include the prevention of bone metastases in men with non-metastatic, castration-resistant prostate cancer. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, metastasis, Prevention, survival, Xgeva | Leave a comment »
Posted on July 18, 2011 by Sitemaster
Denosumab (Xgeva®) has been approved by the European Medicines Agency (EMEA) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors, including prostate cancer, according to a media release issued by Amgen last Friday. … READ MORE …
Filed under: Drugs in development, Management, Treatment | Tagged: denosumab, Europe, skeletal-related events | Leave a comment »
Posted on June 28, 2011 by Sitemaster
As expected (and as previously discussed on this site), Amgen has submitted a supplemental Biologics Licensing Application (sBLA) for denosumab (Xgeva®) for the prevention or the delay of the spread of prostate cancer to bone in men with castrate-resistant prostate cancer (CRPC). … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: Amgen, bone metastasis-free, castration-resistant, denosumab, outcome, survival, Xgeva | Leave a comment »
Posted on May 22, 2011 by Sitemaster
A presentation at the American Urological Association annual meeting in Washington a few days ago provided data that treatment with denosumab (Xgeva) delayed the onset of bone metastasis by 4.2 months compared to treatment with a placebo in men with high-risk, non-metastatic, castration-resistant prostate cancer. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: bone, delay, denosumab, metastasis, survival | Leave a comment »
Posted on May 20, 2011 by Sitemaster
Two drugs already approved in the US that either have been or may be used in the treatment of prostate cancer have now been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: denosumab, ipilimumab, Xgeva, Yervoy | 2 Comments »
Posted on March 4, 2011 by Sitemaster
Full data from the randomized, double-blind, multi-center, Phase III clinical trial comparing denosumab to zoledronic acid in the prevention of skeletal-related events in men with castration-resistant prostate cancer (CRPC) has now been published in The Lancet. … READ MORE …
Filed under: Living with Prostate Cancer, Management, Uncategorized | Tagged: denosumab, Prevention, skeletal-related event, SRE, zoledronic acid | Leave a comment »
Posted on December 14, 2010 by Sitemaster
According to a media release, issued late yesterday by Amgen, treatment with denosumab can significantly improve bone metastasis-free survival compared to treatment with a placebo in men with castrate-resistant prostate cancer (CRPC), a rising PSA, but no evidence of bone metastases. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: delay, denosumab, metastasis, outcome, Prevention, survival | Leave a comment »
THE "NEW" PROSTATE CANCER INFOLINK 