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FDA Grants Two Fast Track Designations to Surufatinib in Pancreatic and Extrapancreatic NETs

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The FDA granted two Fast Track designations to surufatinib (HMPL-012) for the treatment of both advanced and progressive pancreatic neuroendocrine tumors (NETs) and extra-pancreatic (non-pancreatic) NETs in patients who are not amenable for surgery, according to a press release from the developer, Chi-Med. The agent was previously granted Orphan Drug Designation by the FDA for this indication.

Treatment with surufatinib, a VEGFR, FGFR, and CSF-1R inhibitor, prolonged progression-free survival in patients with pancreatic NETs, meeting the primary end point of the pre-planned interim analysis for the phase III SANET-p trial (NCT02589821). This positive results led to early study completion, at the recommendation of the Independent Data Monitoring Committee.2 The full results from the study will be presented at an upcoming medical conference. Read more . . . 

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