NEW YORK—Pfizer Inc. announced that its product Sutent(sunitinib malate) has received recommendation from a United States Food andDrug Administration advisory panel. The U.S. FDA Oncologic Drugs AdvisoryCommittee voted 8-to-2 that Sutent does provide a favorable benefit-riskprofile for treating patients with unresectable pancreatic neuroendocrinetumors (NET). The FDA will consider the panel's recommendation when it finalizesits review of Pfizer's supplemental New Drug Application for Sutent for thisindication.
"We are encouraged by the panel's favorable review ofsunitinib for the treatment of unresectable pancreatic NET. Following today'sdiscussion, we will work closely with the FDA to ensure that it has all of theinformation that it needs to finalize its review," says Dr. Mace Rothenberg,senior vice president of Clinical Development and Medical Affairs at the PfizerOncology Business Unit.
The efficacy of Sutent was studied in a trial, SUN 1111, of171 patients with progressive, well-differentiated pancreatic NET. Tumorprogression in patients taking Sutent stalled for an average time of 11.4months, while those taking a placebo experienced a median time of 5.5 months.Pfizer noted in March 2009 that the study was stopped early on the advice of anindependent monitoring committee, given that it would have been unethical tokeep some of the trial patients on the placebo when Sutent had showed a"significant benefit" and that it was likely that the primaryendpoint—progression-free survival—for the study would be met if it continued.Given the early conclusion, FDA staff agreed that while Sutent stalled tumorprogression for five to six months longer than a placebo, the efficacy mighthave been overestimated due to early termination. Still, the final analysisshowed that Sutent more than doubled the average progression-free survival whencompared to placebo in the 171 patients.
If it secures FDA approval in the U.S., Rothenbergsays that Sutent "would be a major advancement in the treatment of patientswith pancreatic NET, a disease for which there remains a significant unmetmedical need."
In Europe, Sutent is indicated for treating unresectable ormetastatic, well-differentiated pancreatic NET exhibitingdisease progression in adults. It is approved for gastrointestinal stromaltumors after disease progression on or intolerance to imatinib mesylate, aswell as for advanced renal cell carcinoma, and is approved for theseindications in over 100 countries.
Sutent is a multi-kinase inhibitor that blocks multiplemolecular targets implicated in the growth, proliferation and spread of cancer.Two of Sutent's targets, vascular endothelial growth factor receptor andplatelet-derived growth factor receptor, are found in many types of solidtumors and are suspected to play a critical role in tumors acquiring the bloodvessels, oxygen and nutrients they need for growth. Sutent received FDAapproval in 2006 for treating stomach and kidney cancer.
The American Cancer Society's estimates for 2010 were thatabout 43,140 people will have been diagnosed with pancreatic cancer, and about36,800 will have died from it. Pancreatic cancer remains "the fourth leadingcause of cancer death overall," according to the American Cancer Society'swebsite. Pancreatic NET differ from pancreaticadenocarcinoma, which account for about 95 percent of all pancreatic cancers.Advanced pancreatic NET is reported in two to four people per million annuallyworldwide, and accounts for about 22 percent to 28 percent of allneuroendocrine tumors. Pancreatic NET is usually considered to be an indolentdisease, but for patients with pancreatic NET that has metastasized, theprognosis is poor, consisting of a survival of about one to three years.