7.24.2007

SPOTLIGHT: FDA questions satraplatin - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News

SPOTLIGHT: FDA questions satraplatin - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News: "Shares of GPC Biotech and Spectrum Pharmaceuticals took a big hit on Friday after the FDA raised questions regarding their cancer drug satraplatin. 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."