The US Food and Drug Administration (FDA) has approved sunitinib malate (Sutent, Pfizer) as the first anti–vascular endothelial growth factor (VEGF) therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (PNETs) in patients with unresectable, locally advanced, or metastatic disease.
Approval was based on data from the SUN 1111 phase 3 trial, which demonstrated that sunitinib provided a clinically significant improvement in progression-free survival compared with placebo (10.2 versus 5.4 months, P = .000146), as well as a statistically significant improvement in objective response rate of 9.3% (95% CI, 3.2-15.4; P = .0066). No objective responses were observed with placebo.
Sunitinib already is approved for treatment of patients with advanced kidney cancer and those with imatinib-resistant or -intolerant gastrointestinal stromal tumor.