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 [...]
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 [...]
Malecare Cancer Support's Advanced Prostate Cancer Program invites you to our teleconference on Provenge. The Teleconference will begin 6PM EDT, Monday, June 13, 2011. Please register at http://bit.ly/kKuByH Call in number and code will be emailed to you, along with info on how to ask your specific question of our guest. The teleconference will be [...]
Over the last year or so we have seen a marked change in the treatment landscape for men with castrate resistant advanced prostate cancer. The FDA has approved sipuleucel-T (Provenge), cabazitaxel (Jevtana) and last week it also approved abiraterone (Zytiga). This changed landscape of multiple treatment options creates new problems, of course good problems. Prostate [...]
The battle to make sure that Provenge is available nationally (in the United States) to all men who meet the FDA approval requirements is continuing. We have made great steps through the “noise” that the community has made to date. We have successfully reached, what I believe is, the final step in insuring that Provenge [...]
On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]
The Centers for Medicare and Medicaid Services (CME) decided to review their policies pertaining to paying for Provenge, which costs $93,000 per man. Since the hearings which were held a number of months ago, we have not heard any feedback. Despite this, most of the regions have been paying for the treatment, however there have [...]
Malecare has an on-line support group for men with advanced prostate cancer; their loved ones and caretakers. Today, there was a post on the support group where one of the participants shared their recent experience with Provenge, including some very specific recommendations for anyone else thinking of having the treatment. You can join us by [...]
