Spectrum Pharmaceuticals announces that the FDA’s Oncology Drug Advisory Committee (ODAC) will review their very promising investigational drug Satraplatin for the Treatment of Hormone Refractory Prostate Cancer. The hearing will be held on July 24, 2007.
This is very exciting, especially in light of the FDAâ€™s surprising failure to approve Provenge. A quick review of the data that I believe will be presented to the ODAC committee does not seem to have any of the statistical problems that plagued Provenge.
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. I will be there. I will write more about this in the future.Joel T Nowak MA, MSW