The advisory panel recommendation surprised me. Oncology compounds with such strong progression-free survival (PFS) statistics are generally looked upon fondly by the FDA, even without much overall survival data (like Amgen's
A formal PDUFA regulatory review of satraplatin was scheduled to take place Aug. 15, but after the advisory panel recommended that approval of the drug only be granted if overall survival data in its ongoing phase 3 study was positive, GPC withdrew its marketing application.
Formally withdrawing the marketing application, rather than just waiting for the likely approvable letter, was an unusual move. GPC explained on the earnings conference call that it was taking this step to refocus its FDA marketing application on the overall survival data once it is completed. I don't see any advantage to this strategy, since GPC could have gained useful information on any other potential FDA concerns from an approvable letter, then addressed these concerns while waiting for the survival data to come in.
Speaking of the overall survival data, top-line results from the phase 3 study are expected in the next six months. A resubmission of the NDA is guided to occur about a year from now, with a possible PDUFA target date in early 2009.
Interim overall survival data last year showed a trend toward improved survival in satraplatin-treated patients versus placebo. With no other meaningful late-stage pipeline compounds, all eyes will be on GPC's release of the overall survival data next year.
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