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HUTCHMED Receives CRL From FDA For Surufatinib To Treat Advanced Neuroendocrine Tumors

Hutchmed (China) Limited (HCM) announced Monday that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL regarding the New Drug Application or NDA for surufatinib for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors.

The FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States, does not support an approval in the U.S. at this time. The CRL indicated that a multi-regional clinical trial or MRCT 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. They were two randomized double-blind Phase III trials conducted in China in patients with advanced pancreatic or pNETs and extra-pancreatic or epNETs neuroendocrine tumors.

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.

The FDA evaluated the applicability of the SANET studies data generated in one country to U.S. patients and U.S. medical practice. The CRL stated that the FDA will require a MRCT that includes subjects more representative of the US patient population and aligned to current U.S. medical practice.

HUTCHMED said it is working with the FDA to evaluate next steps.

Surufatinib received U.S. FDA Fast Track Designations in April 2020 for the treatment of pNETs and epNETs. Orphan Drug Designation for pNETs was granted in November 2019.

In a May 2020 pre-NDA meeting, HUTCHMED reached an agreement with the FDA that the two positive Phase III studies of surufatinib in patients with pNETs and epNETs in China, along with the bridging trial in the U.S. could form the basis to support a U.S. NDA submission. The FDA accepted the filing of the NDA on June 30, 2021.

On December 29, 2020, surufatinib was granted drug registration approval in China for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA.

Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally."

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