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The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
The FDA has issued a complete response letter for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors (NETs). The FDA indicated that the application, based on two positive phase 3 trials in China and one bridging study in the United States, does not support an approval at this time.
The CRL indicated that a multi-regional clinical trial is required for U.S. approval. The agency would like to see a trial that includes that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice. In addition, pandemic-related issues concerning inspection scheduling and access contributed to the FDA action. This action by the FDA is not related to any safety issues with surufatinib, the company said.
Developed by China-based Hutchmed, surufatinib is an oral inhibitor of angiogenesis and immune modulation. It is angio-immuno kinase inhibitor that inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR). The FDA had accepted the new drug application in July 2021.
“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. We look forward to working with the Agency to evaluate its feedback,” Weiguo Su, chief executive officer and chief scientific officer of Hutchmed, said in a press release.
In the United States, the FDA had granted surufatinib fast track designation and orphan drug designation. This cancer is rare and account for about 7% of all cancers, according to the American Cancer Society, but the occurrence appears to be rising. The ACS predicts about 4,300 people in the United States will be diagnosed with pancreatic NET in 2022.
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. In Europe, an marketing authorization application is under review and in Japan the company is conducting an ongoing Japanese bridging study.