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

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via 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.

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