As of today there are many different potential drugs undergoing phase III evaluations for men with advanced prostate cancer, some of them seem to offer great hope and promise. Considering we just had Provenge finally approved, this is great news. […]
It is truly amazing and very shocking, from 1996 to 1999, the U.S. food and Drug Administration (FDA) approved 157 new drugs. Compared to the period of 2006 to 2009 the FDA approved 74 drugs. However, NOT one of these approved drugs provided a cure for any serious illness! Diseases that destroy lives, diseases like [...]
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 [...]
Watson Pharmaceuticals announced that it has received approval from the FDA for its new six-month intramuscular formulation, Trelstar, a (triptorelin pamoate for injectable suspension) 22.5 mg. Trelstar 22.5 mg is a gonadotropin releasing hormone (GnRH) agonist used for the palliative treatment of advanced prostate cancer. […]
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 [...]
Hormone therapy (ADT), using luteinizing hormone releasing hormone (LHRH) agonists or gonadatropin releasing hormone or GnRH agonists (Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel ) have been known to have many side effects, some severe and potentially life threatening. Many of us believe that ADT is associated with cardiovascular disease and diabetes along with [...]
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 [...]
ABC News has posted a brief story about Provenge. Most of us hope that sometime this week the FDA will finally approve Provenge. To see the brief video interview about Provenge click here. Joel T Nowak, MA, MSW
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 [...]
