How are funding decisions made for Medicare and Medicaid? What drugs are to be funded? These questions have recently come to our attention as many of us have attempted to have Medicare fund our use of Provenge. The administration of Medicare is actually broken into 15 different regions, or MACs (Medicare Administrative Contractors). Each MAC [...]
We have talked about it many times in past posts, the potential that many believe combination therapy can hold for better treatments for all cancers, including advanced prostate cancer. Combination therapy has made AIDS treatment as successful as it has become and it holds a similar promise for cancer treatment. An example of this potential [...]
The National Comprehensive Cancer Network (NCCN), a private organization which develops what has become the standard of care guidelines for clinical practice in oncology, has modified their guidelines to included sipuleucel-T (Provenge) as a part of its prostate cancer management guidelines. The guidelines specify Provenge as a category 1 treatment which is appropriate as salvage [...]
There remain for many people questions about Provenge. The most common question I hear is about the financial cost of the treatment for what has been described as “only 4 months of life extension for $93,000, is it worth it?” Well, the answer is a clear yes! […]
Bavarian Nordic (B/N) is in the process of testing what might be the next prostate cancer vaccine to become available. They have successfully completed a phase II trial of 125 men with metastatic prostate cancer. The good news, the survival advantage experienced by the trial’s subjects had a statistically significantly longer median overall survival of [...]
Provenge has finally received the long awaited approval from the FDA!!! We all celebrate and look forward to benefiting from its potential to extend our life. Provenge is the first immunologic therapy ever approved in the United States to treat cancer. (In Russia, Antigenics has received approval for an immunological treatment for kidney cancer). The [...]
I have received a number of e-mails from men who are both frustrated that Provenge is not yet approved and who are frustrated that even when approved they will not qualify to get the treatment. I understand the frustration and feel the same way. The first question is will the FDA approve Provenge? Only time [...]
According to a Reuters report, a spokeswomen from the FDA said yesterday that, “There is not going to be an additional advisory committee meeting” about the current application for the approval of Provenge. The FDA has the right to convene another meeting to discuss the results of the IMPACT trial, but it now looks as [...]
Provenge, a cancer vaccine, has demonstrated its ability to improve the survival of men with castrate resistant prostate cancer (CRPC). The developer, Dendreon, has submitted it latest clinical trial data to the FDA for approval. We hope to have an approval by mid-year 2010. Growth factors were thought to be potential targets for treating prostate [...]
Is there going to be a competitor to Provenge once it is approved? This is a very interesting question as a second investigational vaccine has shown a significant survival advantage in men with asymptomatic metastatic castration-resistant prostate cancer. There were just released updated results from a phase II trial of PROSTVAC-VF/Tricom vaccine. The trial had [...]
