Friday, January 06, 2012 10:54:19 PM
At the time there was no treatment for this indication. The results were:
median overall survival sorafenib: 10.7 months, placebo: 7.9 months
complete response sorafenib: 0, placebo: 0
partial response sorafenib 2%, placebo: 1%
stable disease sorafenib: 71%, placebo: 67%
So it seems that the approval was all based on the MOS. The UTSW trial of bavi + sorafenib uses
the same dosing of sorafenib. Looks like an unmet need to me.
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