On May 15th I wrote about an application to the FDA for approval of a new treatment Orplatna, trade name of Satraplatin. This hearing, in front of the Oncologic Drugs Advisory Committee (ODAC) is scheduled for July 24 with the session to begin at 1 p.m. Open public comment is projected to begin at 3 p.m. The meeting will be held at the FDA in the Advisors and Consultants Staff Room, Room 1066, 5630 Fishers Lane, Rockville, MD.
I urge you to find a way to the meeting and add your voice to the process. As with the Provenge hearing, the committee serves only in an advisory capacity to the FDA. The ultimate decision whether or not to approve Satraplatin rests solely with the FDA. We need to rally around and urge that ODAC recommends the approval of Satraplatin.
The following is a thumb nail description of Sarraplatin. If you read this summary you will see why this drug is so very important. If approved, it would be the only second line treatment available for men with hormone refractory prostate cancer. Currently, after chemotherapy with Taxotere, which only extends life for an average of 2.5 months coupled with a significant degradation of the quality of life, we have no treatments! This is not an acceptable situation for men with advanced prostate cancer.
The SPARC trial showed that hormone refractory prostate cancer patients who received Satraplatin plus Prednisone had a 40% reduction in the risk to disease progression (hazard ratio of 0.6, 95% Confidence Interval:0.5-0.7) compared to patients who only received Prednisone plus a placebo! This progression free survival (PFS) was highly statistically significant (p<0.00001). In addition, the company claims that t