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 [...]