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

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