CME Advisory Committee Supports Medicare Payments for Provenge for Men Meeting the FDA Guidelines

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 [...]

Out On the Limb – Predicting the CME Decision on Provenge

Today, I spent most of the day listening to the CME (Medicare & Medicaid) hearing on Provenge. CME does not have to abide to the decisions of the advisory committee, so like we experienced with the FDA Advisory Committees we will have to wait and see what will eventually become the policy for reimbursement. I [...]

Calling Dendreon’s Call Center & Being Told To Call Back

I have heard back that a number of people have contacted the call center at Dendreon (877-336-3736) and been told to call back at a later date for specific information about getting treatment. I have spoken with Dendreon and they have explained that they are working with the various infusion centers on mapping out specific [...]

Dendreon Finally Completes Its FDA Submission for the Approval of Provenge

Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]

Some Findings From The Early Study of Provenge in Men with Early Stage Recurrent Prostate Cancer

There was just a release of some of the data from the on-going review sipuleucel-T, or Provenge, in men with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic prostate cancer. The data wes presented by Oregon Health & Realm University Cancer [...]

Data Released to the Investors of Dendreon A Head of the AUA Meeting

Prior to the AUA meeting Dendreon released the following to its investors. We will now wait to see what transpires at the AUA meeting which is scheduled to be held in one and a half hours from my posting this. Joel T Nowak MA, MSW – Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival [...]

Waiting On the Side Line with Crossed Fingures and A Prayer

I don't know about you, but I am waiting very anxiously for today's presentation at the AUA conference from Dendreon about Provenge. It is an absolute shame that we have been put into the position that we needed to wait for more men to die before moving ahead. I am concerned that all of the [...]

Dendreon Announces Data Presentations and Webcast on their Experimental Immunotherapy Provenge

Press Release: Dendreon Corporation (Nasdaq: DNDN) announced the following data presentations taking place at the American Urological Association's (AUA) Annual Meeting in Chicago, as well as a Dendreon-sponsored IMPACT data webcast conference call: (for those of us who will be unable to attend the session at AUA in Chicago) April 28, 2009, 2:20 p.m. CDT-"A [...]

About Provenge

As a follow up to yesterday's news about the positive results announced about Provenge, I have received a number of private emails asking questions about the treatment. I hope that the following will answer many of the questions people might still have about Provenge. • The other name for Provenge is sipuleucel-T. • Provenge is [...]

PROVENGE Significantly Prolongs Survival in Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

What great news has greeted us today. We can now hope that the FDA will quickly approve Provenge and we can get this sorely needed treatment ASAP. If Provenge gets approval from the FDA it will be the first cancer vaccine ever approved. Sadly it will be only the second approved treatment for prostate cancer! [...]