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Denosumab (Xgeva) Benefits Greatest in Men with Rapid PSA Kinetics

Denosumab (Xgeva), the recently approved and only therapy that prolongs bone metastasis-free survival in men with non-metastatic castrate-resistant prostate cancer (CRPC) who are at high risk for the spread of prostate cancer metastasis to bone seems to work best in men with very rapid prostate specific antigen (PSA) kinetics. The large 1,432 man, placebo controlled, [...]

XGEVA Delays The Onset Of Bone Metastases In Men With Non-Metastastic Castrate Resistant Prostate Cancer

Amgen announced that they have published the results from their Phase 3 trial (the '147 study) that evaluated XGEVA® (denosumab) for use in preventing or delaying the onset of bone metastases in men with non-metastatic castration-resistant prostate cancer (CRPC). The results were published in The Lancet. The study found XGEVA significantly prolonged bone metastasis-free survival, [...]

FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Men with Prostate Cancer Undergoing ADT

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in men receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer. Men receiving ADT are at high risk for developing fractures, including vertebral fractures, which can cause paralysis. "Bone loss [...]

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 [...]

Request for the Approval of Denosumab to Protect Bones in Men with Advanced Prostate Cancer

Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. Although some doctors have already begun to use Xgeva in men with advanced prostate cancer, it is [...]

On the Horizon – Denosumab (Xgeva) to Slow the Development of Bone Mets

Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer [...]

On The Horizon – Xgeva (denosumab) To Prevent or Slow Down Bone Mets

Yesterday, Amgen announced that it had submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its license for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or [...]

Should Men on ADT Take Calcium and Vitamin D Supplementation?

As usual with prostate cancer there is no general agreement about whether or not men who are on a hormone blockade (ADT) to treat prostate cancer should be taking calcium and vitamin D supplements, however there does seem to be some consensus that they should. Given that there are geographic and seasonal variations in vitamin [...]

Denosumab delays the Spread of Prostate Cancer to the Bones, But it Doesn’t Extend Life!

Results from a recent clinical trial indicate that denosumab delayed the spread of prostate cancer metastases bones, however it did not prolong the lives of men. […]

FDA Questions Denosumab Safety in Advisory Meeting Documents

Just revealed in briefing documents which were released in advance of a scheduled Thursday meeting of the FDA’s Advisory Committee for Reproductive Health Drugs, which will be considering whether to recommend denosumab for approval, are significant concerns that denosumab, the investigational biologic drug for osteoporosis, may increase risk of serious infections through its activity against [...]

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