Pharma Blog Watch

Committee Urges Approval for Cancer Drug (DrugWonks)
In his entry, Robert Goldberg calls the Cellular, Tissue and Gene Therapies Advisory Committee's recommendation to the FDA to approve Dendreon's prostate cancer treatment Provenge a victory for cancer patients.

The committee reviewed subpopulation data and made its decision based on whether the drug "was effective, as opposed to asking [if] the drug was substantially effective for an entire population," he writes, and recommended approval "despite the fact that developer Dendreon has hardly begun to enroll patients in the postmarket trials the FDA and its safety-mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding."