FDA expands approval of denosumab in men with advanced prostate cancer

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 …

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 …

Denosumab approved in Europe for treatment of SREs

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 …

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 …

Impact of denosumab on bone metastasis-free survival

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 …

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 …

Lancet publishes data on denosumab in men with mCRPC

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 …

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