Hutchmed Ltd said on Monday the US Food and Drug Administration has declined to approve its cancer drug, citing the need for a multi-regional clinical trial, becoming the second China-tested drug to be rejected by the US regulator this year.
In its so-called complete response letter to the company, the FDA said current drug data, based on two trials in China and one bridging study in the United States, does not support an approval in the United States at this time.
Hutchmed was seeking approval for its drug surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors, a condition that has a few treatment options. The FDA in March declined to approve Eli Lilly and partner Innovent Biologics Inc's lung cancer drug that had been studied only in China.
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