HCM - Hutchmed stock falls as FDA rejects surufatinib to treat neuroendocrine tumors

The U.S. Food and Drug Administration (FDA) rejected Hutchmed's (China) (NASDAQ:HCM) application seeking approval of surufatinib to treat certain neuroendocrine tumors, noting that the data submitted did not support an approval and a multi-regional clinical trial is required. The FDA had accepted to review the company's new drug application (NDA) for surufatinib to treat treat pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors (NETs) last year. Hutchmed (HCM) said that in the FDA's complete response letter the U.S regulator determined that the current data package, which was based on two phase 3 trials in China and one bridging study in the U.S., does not support an approval in the U.S. at this time. The letter also indicated that a multi-regional clinical trial that includes people more representative of the U.S. patient population and aligned to current U.S. medical practice, the company said in a May 2 release. The company added that pandemic-related issues concerning

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Hutchmed stock falls as FDA rejects surufatinib to treat neuroendocrine tumors