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In issuing final draft guidance on the coverage of treatment with denosumab (Xgeva) for patients with metastases to the bones, the National Institute for Clinical Excellence (NICE) in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

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 …

Approval of denosumab for extension of metastasis-free survival in the USA?

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 …

Amgen requests expanded indication for denosumab

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 …

Two new drugs recommended for approval in Europe

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 …

US FDA approves Xgeva for prevention of “skeletal-related events”

According to a media release from Amgen, issued late yesterday, the US Food & Drug Administration (FDA) has approved denosumab (to be known by the brand name Xgeva™) for “prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.” This indication would include patients with prostate cancer and evident bone metastasis. … READ MORE …