An FDA expert committee has dealt a blow to GPC Biotech, concluding unanimously that regulators should wait for survival data before approving its prostate cancer drug Orplatna (satraplatin). The news triggered a rout among investors as GPC's stock slid 42 percent, wiping out $310 million of valuation. Shares of Spectrum Pharmaceuticals as well as Pharmion, GPC's partners on the drug, both slipped.
The committee wants to see if volunteers taking the pill in a trial lived longer than the placebo arm. Interim data from last summer demonstrated no improvement in survival rates and the company says that it could be another year before the new batch of data would be available. GPC based its application on the potential benefit for patients who had not responded to other treatments. Progression-free survival for the group on the drug was 11.1 weeks compared to 9.7 weeks for patients taking a placebo.
- see the release
- here's the AP report on the committee vote