Pfizer Inc. (PFE), said Tuesday its oral multi-kinase inhibitor Sutent was determined as having a favorable benefit-risk profile by an oncology advisory committee of the FDA for the treatment of unresectable pancreatic neuroendocrine tumors. The panel voted 8-2 in favor of Sutent.
Advanced pancreatic neuroendocrine tumor or NET, is a rare, life-threatening and difficult-to-treat form of cancer that accounts for approximately 22-28 percent of all neuroendocrine tumors.
While pancreatic NET is typically considered an indolent disease, nearly 90 percent of patients are initially diagnosed with locally advanced or metastatic disease, or cancer that has spread to other organs. An unresectable tumor is one that cannot be removed or resected by surgery.
Earlier Tuesday, Novartis International AG (NVS), reported an unanimous recommendation by the same committee for its Afinitor or Everolimus to treat patients with advanced NETs of pancreatic origin.
Sutent or sunitinib malate targets vascular endothelial growth factor receptor or VEGFR and platelet-derived growth factor receptor or PDGFR, both of which are expressed by many types of solid tumors. The two targets are involved in tumors acquiring blood vessels, oxygen and nutrients needed for growth.
In February 2009, the independent Data Monitoring Committee for the SUN 1111 trial had determined strong likelihood that sunitinib would meet its primary endpoint, progression-free survival. It therefore recommended that randomization to the study be halted in the interest of patient safety. In final results, the drug lived up to its backing, more than doubling median progression-free survival compared with placebo in 171 patients with progressive, well-differentiated pancreatic NET.
Further, sunitinib also demonstrated advantages in overall survival, objective response rate and patient reported outcomes.
To date, more than 100,000 patients have been treated with Sutent worldwide for gastrointestinal stromal tumors after disease progression, and advanced renal cell carcinoma.
The panel's advice will be considered by the FDA when finalizing Pfizer's supplemental New Drug Application or sNDA for sunitinib for the NET indication.
PFE closed Tuesday's regular trading at $20.46, down $0.21 or 1.02%, on the NYSE.
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