Complete Response Letter from the FDA for surufatinib for the treatment of advanced neuroendocrine tumors.
HUTCHMED (China) Limited announced that the FDA has issued a Complete Response Letter (“CRL”) regarding the New Drug Application for surufatinib for the treatment of pancreatic (“pNETs”) and extra-pancreatic (non-pancreatic, “epNETs”) neuroendocrine tumors (“NETs”).
FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States (U.S.), does not support an approval in the U.S. at this time. The CRL indicated that a multi-regional clinical trial is required for U.S. approval.
The safety and efficacy of surufatinib, an oral inhibitor of angiogenesis and immune modulation, was demonstrated in the SANET-p and SANET-ep studies, two randomized double-blind Phase III trials in patients with advanced pNETs and epNETs conducted in China. Results of a HUTCHMED sponsored bridging study conducted in the U.S. suggest similar safety and efficacy to the SANET study population in China. Surufatinib was approved in China for the treatment of pNETs and epNETs in June 2021 and December 2020, respectively.
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