The company is attempting to gain approval for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC).
Satraplatin for this indication was granted fast track designation by the FDA in September 2003. The designation permits a rolling submission of the new drug application so that the review process can begin before the complete dossier has been submitted.
The company submitted the chemistry, manufacturing and controls section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006.
“The non-clinical section is the second of three parts necessary to complete the NDA submission. We are very pleased that we continue to make such good progress in advancing satraplatin toward the market and that we remain on track with our timelines,” said Dr Bernd Seizinger, CEO.