Spectrum Pharmaceuticals announced that its partner, GPC Biotech, has submitted the non-clinical section of the rolling submission of a new drug application (NDA) to the FDA for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC).
GPC submitted the chemistry, manufacturing and controls section of the NDA in December 2005 and anticipates completing the NDA submission by the end of 2006. Under Spectrum's agreement with GPC for satraplatin, GPC is responsible for fully funding the development and regulatory expenses and will pay Spectrum royalties based on sales of this compound.
The FDA granted fast track designation for satraplatin in September 2003. The FDA's fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.