German biotechnology company GPC Biotech has started a rolling submission in the USA for its lead drug satraplatin as a second-line chemotherapy treatment in combination with prednisone for patients with hormone-refractory prostate cancer.

To begin the review process, GPC Biotech has submitted the chemistry, manufacturing and controls - or CMC - section of the New Drug Application filing to the US Food and Drug Administration.

Satraplatin is an orally-active platinum-containing cancer drug that has been recommended for ‘fast-track’ review by the FDA, intended to speed up the approval of drugs that offer particularly strong clinical benefits. Worldwide sales of platinum cancer drugs exceeded $2.2 billion dollars in 2004, and it is estimated that satraplatin itself could achieve revenues of 500 million euros at peak.

The compound is currently in Phase III testing for prostate cancer, and has also completed Phase II trials in ovarian cancer and small cell lung cancer, and has started Phase II testing in breast cancer.