Posted by Michael Wonder on 03 May 2022
HutchMed receives complete response letter from the U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
2 May 2022 - HutchMed announced that the U.S. FDA has issued a complete response letter regarding the new drug application for surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumours.
The FDA determined that the current data package, based on two positive Phase 3 trials in China and one bridging study in the U.S. does not support an approval in the U.S. at this time.
The letter indicated that a multi-regional clinical trial is required for U.S. approval.
