US Bridging Study Not Enough as FDA Denies Hutchmed's Pancreatic Cancer Drug

China-based Hutchmed failed to get the U.S. Food and Drug Administration's approval for its proposed drug for pancreatic cancer.

In a Complete Response Letter, the FDA said that it cannot approve the New Drug Application (NDA) for surufatinib for pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors because of insufficient results in both the two Phase III trials that Hutchmed conducted in China and one bridging study in the U.S.