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Benzinga

Technology

Ragothaman Srinivasan

U.S. FDA Rejects HUTCHMED's New Drug Application For Surufatinib In Neuroendocrine Tumors

FDA Hutchmed China

HUTCHMED (China) Limited (NASDAQ:HCM) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).

The regulatory agency determined that the current data package, based on two positive Phase III trials in China and one bridging study in U.S. does not support an approval in the United States at this time.

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