Replies to post #115141 on Biotech Values

[jq1234]

didn't Tarceva show only a few week (or somewhere around there) PFS benefit and they were approved?

Tarceva showed OS benefit in both 2nd/3rd line and maintenance setting. However, the benefit was much larger in 2nd/3rd line than maintenance setting. Due to relatively small benefit in maintenance setting, ODAC voted down overwhelmingly in maintenance setting by 12 to 1 margin. FDA went against ODAC on maintenance setting. The point is, even though it showed both PFS and OS advantage statistically, the argument about clinical benefit is not going away if the benefit is so small.