The submission is being made for satraplatin to be used in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). GCP Biotech has submitted to the FDA the chemistry, manufacturing and controls section of the NDA filing.
GPC Biotech’s drug has already been awarded fast track status by the US regulatory authority, enabling it to make the rolling submission. Such a submission allows companies to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.
The FDA’s fast track programs are intended to expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The FDA granted fast track designation to satraplatin as a second-line chemotherapy treatment for patients with HRPC in September 2003.
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. According to GCP Biotech, worldwide sales of these drugs exceeded $2.2 billion in 2004.
Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications.