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. [...]
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 [...]
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 FDA’s surprising failure to approve Provenge. A quick review of [...]