Yesterday Dendreon, the producers of Provenge, received word from the FDA that their plant in California had been approved to manufacture Provenge. This afternoon they received a positive response from the Centers for Medicare and Medicaid Services (CMS) that a final National Coverage Decision (NCD) for Provenge has been issued requiring Medicare contractors to cover [...]
Early this evening Dendreon received the nod from the FDA to use their new manufacturing plant in Seal Beach, California. The approval of this plant will allow the company to now service the men with advanced prostate cancer in Hawaii as well as more efficiently service those in Western United States with Provenge. When coupling [...]
Darryl, the Malecare Executive Director, posted an organizational response to yesterday's New York Times Article on the newly approved advanced prostate cancer drugs and their economic impact. I thought that I would share his insightful post with everyone. "We can easily price commodities and drugs to whatever the market will bare, but how do we [...]
Today’s New York Times carried a front page article about the high cost of the new prostate cancer treatments. This article seems to be the talk of the town and the talk (based on the comments that have been entered on-line) has been anything but positive. Unfortunately, many of the comments have made with the [...]
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. […]
There is a constant debate between both oncologist and advocates about the value and safety of 5-alpha-reductase inhibitors (Proscar and Avodart) both in the early treatment and later treatment of men with prostate cancer. In fact, I have had an on-going private debate with one very knowledgeable educator advocate over this issue. I often have [...]
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 [...]
In anticipation of our Monday night teleconference on Provenge (see below for registration procedures) I am very happy to report that Dendreon is now detailing plans to move Provenge to earlier stages in the disease’s progress. At the American Society of Clinical Oncology (ASCO) meeting in Chicago which is winding down today, Dendreon unveiled plans [...]
