Denosumab therapy and risk for severe hypocalcemia

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 …

NICE rejects denosumab for bone mets in men with advanced prostate cancer

In issuing final draft guidance on the coverage of treatment with denosumab (Xgeva) for patients with metastases to the bones, the National Institute for Clinical Excellence (NICE) in England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 …

NICE rejects clinical use of denosumab in men with metastatic prostate cancer

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 …

FDA rejects expanded indication for denosumab, as expected

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 …

Advisory panel does NOT recommend approval of Xgeva for prevention of bone mets

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 …

Will denosumab gain approval for prevention of onset of metastasis to bone?

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 …

Denosumab and delay of onset of bone metastasis

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 …