The U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted 8-2 that Sutent (sunitinib malate) provides a favorable benefit-risk profile for the treatment of unresectable pancreatic neuroendocrine tumors (NET). The panel's advice will be considered by the FDA when finalizing its review of Pfizer's supplemental New Drug Application (sNDA) for sunitinib for this indication.
"We are encouraged by the panel's favorable review of sunitinib for the treatment of unresectable pancreatic NET. Following today's discussion, we will work closely with the FDA to ensure that it has all of the information that it needs to finalize its review," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "If approved in the United States, sunitinib would be a major advancement in the treatment of patients with pancreatic NET, a disease for which there remains a significant unmet medical need."
In February 2009, the independent Data Monitoring Committee for the SUN 1111 trial recommended that randomization to the study be halted in the interest of patient safety and based on the very strong likelihood that the study would meet its primary endpoint if continued to completion. In the final analysis, it was demonstrated that sunitnib more than doubled median progression-free survival (PFS), the primary endpoint, compared with placebo in 171 patients with progressive, well-differentiated pancreatic NET. An advantage for sunitinib was also observed in the secondary endpoints of overall survival, objective response rate and patient reported outcomes.
Adverse events observed with sunitinib were consistent with the known safety profile for the therapy.
In Europe, as of November 2010, Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression in adults. Experience with Sutent as initial treatment in this disease is limited.
Source: Pfizer Oncology
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