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 a Hutchmed-sponsored bridging study conducted in the U.S. that suggested safety and efficacy similar to that observed in the Chinese study population.
However, the FDA complete response letter stated that a multiregional clinical trial with individuals more representative of the U.S. patient population and in accordance with U.S. medical practice will be required, the press release stated.
Pandemic-related issues regarding scheduling of inspections and access contributed to the FDA’s decision, which was unrelated to any safety issues, according to Hutchmed officials.
“Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for [patients with neuroendocrine tumors] and committed to making surufatinib available to patients globally,” Weiguo Su, PhD, CEO and chief scientific officer of Hutchmed, said in a press release. “We look forward to working with the agency to evaluate its feedback.”
The FDA granted fast track designation to surufatinib in April 2020 for treatment of pancreatic and extra-pancreatic neuroendocrine tumors, and the agent has been approved in China for these indications.