Hutchmed Reports the US FDA’s Acceptance of Surufatinib’s NDA for Advanced Neuroendocrine Tumors

July 2, 2021 Auto Bot Acceptance, FDA, Hutchmed, NDA, regulatory 0

Shots:

  • The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is April 30, 2022
  • The same data from the studies will be used to file MAA to the EMA imminently, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use
  • Surufatinib received FTD in Apr’20 and ODD in Nov’19 for the treatment of pancreatic and extra-pancreatic NET. Hutchmed currently retains all rights to surufatinib globally

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