HUTCHMED : FDA Rejects Surufatinib Application in Neuroendocrine Tumors

 HUTCHMED (China) Ltd. on Monday said the U.S. Food and Drug Administration has turned away its application seeking approval of surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors and wants the biopharmaceutical company to conduct another study.

The Hong Kong company said the FDA determined that its current data package, based on two positive Phase III trials in China and one bridging study in the U.S., doesn't support an approval in the U.S., and that a multi-regional clinical trial that includes subjects more representative of the U.S. patient population and aligned to current U.S. medical practice is needed.

HUTCHMED said the FDA issued a so-called complete response letter, which indicates the agency won't approve the application in its current form.

The company noted that the FDA's action isn't related to any safety issues with surufatinib, adding that it is working with the agency to evaluate its next steps.

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