It wasn't perfect for Pfizer
Yesterday a Food and Drug Administration advisory committee voted 8-2 recommending approval of Sutent to treat pancreatic neuroendocrine tumors. The agency doesn't have to follow the recommendation from the panel of experts, but the vote was by a wide enough margin that it seems likely the FDA will follow along.
The committee didn't let Pfizer off scot-free though, requesting additional information on the magnitude of the effect of Sutent in the rare cancer type. Pfizer stopped the clinical trial early because it was clear the drug was working, but that makes it difficult to know exactly how well it works. The agency will likely require Pfizer to run a post-approval clinical trial to determine exactly how well Sutent works in pancreatic neuroendocrine tumors.
While certainly positive, the advisory panel wasn't a make-or-break event for either company. Pfizer and Novartis are both large companies and the number of patients with pancreatic neuroendocrine tumors is relatively small. Both drugs are approved to treat kidney cancer -- Sutent as a front-line treatment and Afinitor only after patients have failed Sutent or Nexavar from Bayer and Onyx Pharmaceuticals
The next advisory panel meeting, April 27-28, will have a little more significance. Merck's
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