FDA panel votes in favour of Sunitib (Sutent) for pancreatic tumors

By Dr. Ananya Mandal, MDApr 12 2011

Pfizer Inc. announced this Tuesday that its oral multi-kinase inhibitor Sutent was determined as having a favourable 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 favour of Sutent – generically called Sunitib malate.

Advanced pancreatic neuroendocrine tumour or NET, is a rare, life-threatening and difficult-to-treat form of cancer that accounts for approximately 22-28 percent of all neuroendocrine tumours. Nearly 90 percent of patients are initially diagnosed with locally advanced or metastatic disease, or cancer that has spread to other organs. An unresectable tumour is one that cannot be removed or resected by surgery.

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 tumours. The two targets are involved in tumours acquiring blood vessels, oxygen and nutrients needed for growth.

In a February 2009, independent Data Monitoring Committee for the SUN 1111 trial it was hoped that sunitinib would meet its primary endpoint - progression-free survival. 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 tumours 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.

Sunitinib was approved in 2006 in the United States for treating locally advanced or metastatic renal cell carcinoma and for imatinib-refractory or -intolerant gastrointestinal stromal tumour (GIST). It was approved for treating PNET in 2010 in Europe. A decision on approval is expected by the end of 2011, according to a company spokesperson

In similar news, Novartis International AG also made an announcement this Tuesday regarding a unanimous recommendation by the same committee for its Afinitor or Everolimus to treat patients with advanced NETs of pancreatic origin.