THE FDA HAS APPROVED PROVENGE

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 [...]

Provenge, Its Future & A Clinical Trail Alternative for Men with Hormone Dependent Prostate Cancer

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 [...]

No Additional Hearing at the FDA for Provenge

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 [...]

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 [...]

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