May 23, 2011
Sutent Gains Indication for Advanced Pancreatic TumorsThe FDA has approved Sutent (sunitinib malate; Pfizer) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease. This approval was based on data from SUN1111, a Phase 3 multicenter, international, randomized, double-blind, placebo-controlled trial that demonstrated that Sutent provided a clinically significant improvement in progression-free survival compared to placebo (10.2 vs. 5.4 months, P=0.000146) in this patient population.
Treatment with Sutent also yielded a statistically significant improvement in tumor response, with an objective response rate of 9.3% (95% CI: 3.2–15.4, P=0.0066). No objective responses were observed with placebo. In addition, while overall survival was not mature at the time of final analysis, nine deaths were observed in patients enrolled in the Sutent arm versus 21 deaths in patients enrolled in the placebo arm.
Sutent is already indicated for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate and for advanced renal cell carcinoma.
For more information call (800) 438-1985 or visit www.sutent.com.