FDA rejects new drug application for surufatinib to treat advanced neuroendocrine tumors

The FDA has informed Hutchmed Ltd. that the data package included in a new drug application for surufatinib to treat pancreatic and extra-pancreatic neuroendocrine tumors does not support approval in the U.S., the company announced.The application included results of two randomized, double-blind, phase 3 trials in China that showed efficacy and safety of surufatinib, an oral inhibitor of angiogenesis and immune modulation, among patients with advanced pancreatic and extra-pancreatic neuroendocrine tumors, according to a Hutchmed press release. The company also submitted data from aRead More