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 the improvement seen in progression-free survival of those patients who received Satraplatin increased over time.This phase 3 trial was a double blinded, randomized, and placebo-controlled and was multinational. The sample size was 950 and patients were accrued from over 200 clinical sights from fifteen countries.Satraplatin is a fourth generation, orally administered drug. It is a member of the platinum family of compounds. Over the last 20 years, platinum drugs have been used to treat many different cancers. In the case of Satraplatin, administration of the drug is oral as apposed to all other cancers, which are administered by an infusion.Being a second line treatment, Satraplatin would be used after the failure of chemotherapy with Taxotere (first line treatment). Right now, once chemotherapy has failed, there are not any other treatments available to patients with advanced prostate cancer. If ODAC and the FDA approve Satraplatin, we will finally add one more arrow in our quiver.I call upon the prostate cancer community to turn out at the ODAC committee meeting and actively and loudly support the approval of Satraplatin.
To register to provide public comment you should contact: Johanna Clifford at the FDA prior to July 2, 2007. Her telephone number is 301-827-6761 or contact her by email at: Johanna.Clifford@fda.hhs.gov
If you are unable to attend please register your support electronically for Satraplatin at: http://www.fda.gov/cder/comment.htm
Title your comments as: Satraplatin NDA 021-801
I will be there. I hope to see you.
As the great prophet Hillel said, “If I am not for myself, then who would be for me.”
Joel T Nowak MA, MSW
While I am all for adding as many arrows to a cancer patient’s quiver as are possible and letting patients decide which risks to take and which not to, a quick clarification is in order.
To date, Satraplatin has failed to demonstrate a statistically significant improvement in overall survival. Progression-Free Survival very often has little or no correlation to overall survival because it may not be the primary tumor growth/progression that kills.
PFS is fine, but don’t confuse it with increasing cancer patients lives, which Satraplatin has not yet been shown to do, which means so far it’s less effective than Taxotere, which isn’t a claim I’d be looking to make were I trying to market to cancer patients, so of course, they harp on PFS. Just something to think about.