Shares of GPC Biotech and Spectrum Pharmaceuticals took a big hit on Friday after the FDA raised questions regarding their cancer drug satraplatin [1]. Analysts were alarmed that the agency was highlighting a disagreement between two radiologists over the progression of prostate cancer in patients who have failed to respond to chemotherapy. Reviewers may ask for a delay on any decision until final survival data is in. An expert FDA panel is scheduled to review the drug this week. Report [2]
Links:
[1] http://www.fiercebiotech.com/story/phase-iii-data-backs-satraplatin-for-prostate-cancer/2007-02-23
[2] http://www.ocbj.com/industry_article.asp?aID=68549769.3400797.1502306.45722.5759531.246&aID2=115553