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news.Pfizer has received the US Food and Drug Administration (FDA) approval for SUTENT, an anti-VEGF therapy to treat pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease.
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SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.
The FDA approval is based on data from the SUN 1111 pivotal Phase 3 trial.
SUN 1111 is a randomized, double-blind, placebo-controlled Phase 3 study (n=171) evaluating single-agent SUTENT in patients with unresectable pancreatic NET, characterized by cancer that could not be surgically removed.
The primary endpoint is progression-free survival.
Other endpoints included overall survival, objective response rate and safety.
SUTENT is also approved for both gastrointestinal stromal tumors (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced renal cell carcinoma (RCC).