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 [...]
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 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 [...]
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 [...]
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 [...]
Regeneron Pharmaceuticals, Inc. announced that the Phase 3 VENICE clinical trial evaluating the investigational agent Zaltrap (aflibercept) in the first-line treatment of men with castrate resistant prostate cancer will continue to completion as planned. They have not been asked to make any modifications due to efficacy or to safety concerns. This decision is based on [...]
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 [...]
According to findings from a long term study, men with prostate cancer (PCa) who are treated with degarelix (a newly approved gonadotropin-releasing hormone receptor (GnRH) blocker) have a lower risk of PSA failure or death compared with those treated with leuprolide. […]
Data from the recent ASCO conference on a phase II study of cabozantinib (XL184) in patients with advanced solid tumors, including prostate cancer, demonstrates that the investigational treatment has activity in both bone and soft tissue. This study evaluated the efficacy and safety of cabozantinib compared to placebo in 9 different solid tumor types including [...]
There is good reason for guarded optimism among men with advanced prostate cancer. Over the last 2 years we have seen some significant movement with the development of new drugs and treatments for men with advanced prostate cancer. All of these drugs have demonstrated a survival advantage in their clinical trials. Each of the agents [...]
