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Drug Duo Escapes Advisory Panel Unharmed

By Brian Orelli, PhD - Updated Apr 6, 2017 at 10:25PM

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Pfizer and Novartis are on their way to expanding their cancer drug indications.

It wasn't perfect for Pfizer (NYSE: PFE), but it should be enough to get the drug approved.

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.

Novartis's (NYSE: NVS) Afinitor was also up for review at the same advisory committee, but the company had an easier time, breezing by with a unanimous recommendation for approval.

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 (Nasdaq: ONXX). They'll continue to make more money selling the drug for that cancer type than they will for pancreatic neuroendocrine tumors, assuming the FDA signs off on the approvals.

The next advisory panel meeting, April 27-28, will have a little more significance. Merck's (NYSE: MRK) hepatitis C drug boceprevir goes first followed by Vertex Pharmaceuticals' (Nasdaq: VRTX) telaprevir the following day. Like pancreatic neuroendocrine tumors, hepatitis C is a disease in desperate need of better treatments. Unlike pancreatic neuroendocrine tumors though, hepatitis C is a very large market with some 3.2 million people in the U.S. alone.

Get ready for Merck's and Vertex's advisory panels by adding them to your watchlist. Click on their names and they'll be added to My Watchlist, which will help you keep track of all our Foolish analysis on the companies.

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Stocks Mentioned

Pfizer Inc. Stock Quote
Pfizer Inc.
$53.91 (-0.15%) $0.08
Novartis AG Stock Quote
Novartis AG
$91.46 (0.22%) $0.20
Merck & Co., Inc. Stock Quote
Merck & Co., Inc.
$93.08 (0.83%) $0.77
Vertex Pharmaceuticals Incorporated Stock Quote
Vertex Pharmaceuticals Incorporated
$273.73 (1.51%) $4.08

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