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 [...]

A Provenge Like Treatment Demonstrates Extraordinary Results Treating Leukemia – A Phase I Trial Using the Technique In Post Chemo Prostate Cancer Treatment

The most exciting news today is about some research performed at the University of Pennsylvania where researchers took blood from the three leukemia patients and isolated the T cells, a type of immune cell in the blood. T cells recognize invading organisms and kill them, however they do not recognize cancer cells as invading cells, [...]

Clinical Trials for Prostate Cancer: Myths & Facts

Clinical trials are important both for your treatment and for the purpose of advancing our knowledge about drugs and treatments against prostate cancer. The treatment of advanced and recurrent prostate cancer has made significant steps over the last 2 years, but without the active participation of all of us our progress will be slowed, perhaps [...]

Intermittent Androgen Deprivation (IAD)- No Longer Considered Experimental for Treating Men with Advanced Prostate Cancer

Changing the Standard of Care for Men with Recurrent and Advanced Prostate Cancer, Men receiving androgen deprivation therapy (ADT) for the treatment of advanced or metastatic prostate cancer know all to well the terrible side effects this treatment modality can cause. These side effects can include fatigue, hot flashes, mood swings, inability to concentrate as [...]

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 [...]

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