Yesterday, I traveled to the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) where they reviewed the application for approval of Satraplatin (see my prior posts). The committee voted 12-0 recommending that the FDA delay the approval until all of the final survival data from the SPARC trial becomes available.
This translates to the company (“GPC Biotech AG on the Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) waiting for 700 men from the SPARC trial of 940 to die!
A representative of the company told me that at the earliest this data could become available would be in the final quarter of 2008. Once the data has matured (the 700 men die) it will have to be analyzed and presented to the FDA at an additional review.
The FDA is not bound to this recommendation from ODAC, but I cannot see any possibility of their not following the recommendation.
You can see the company’s complete press release at:
I will be posting additional information about Satraplatin as well as my testimony later today or tomorrow.
Once again, men with Prostate cancer have been denied a drug. We have only one chemotherapy drug available (Taxotere) and it seems that our deaths are not so important. One of the ODAC members did make some disparaging remarks and blamed the biotech industry for their failure to bring drugs to the market. I do not entirely disagree, but the real culprit is the federal government who has continually denied adequate funding for prostate cancer research. I also believe that the FDA has chosen to ignore their own regulations pertaining to surrogate end-points. I will also explain this in future posts.
Joel T Nowak MA, MSW