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# Fast Track for Surufatinib in Pancreatic Neuroendocrine Tumors
- URL: https://www.fdaweb.com/fast-track-for-surufatinib-in-pancreatic-neuroendocrine-tumors/
- Published: 2020-04-17T12:00:00.000Z
- Updated: 2026-09-14T16:11:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146594

FDA has granted Hutchison China MediTech two fast track designations for surufatinib for treating both advanced and progressive pancreatic neuroendocrine tumors (NET) and non-pancreatic NET in patients who are not amenable for surgery. The company describes surufatinib as a novel, oral angio-immuno kinase inhibitor that “selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells.” It says the therapy’s unique dual mechanism of action may be suited for possible combinations with other immunotherapies.

Hutchison says it is preparing for regulatory discussions with FDA to confirm clinical development based on data from the two positive Phase 3 studies of surufatinib in NET in China, and an ongoing multi-cohort Phase 1b study in the U.S. (clinicaltrials.gov identifier: [NCT02549937](https://www.globenewswire.com/Tracker?data=uXifBxh1w0hTac-4h7U6oeWYDFYwDSnHZu%5Fr3HYmTCCEbrU3Rh2aKFW0M8E5Zyx3Y2Irb7vB4mxDnX4rsPL0C-5YtDjaP%5FhAkIoOE8gPMIQ=&mod=article%5Finline&ref=fdaweb.com)). Surufatinib was also granted an orphan drug designation for pancreatic NET 11/2019.