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Surufatinib FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 12, 2021.

FDA Approved: No
Generic name: surufatinib
Company: Hutchison China MediTech Limited
Treatment for: Neuroendocrine Tumors

Surufatinib is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”).

Development timeline for surufatinib

DateArticle
May  4, 2022Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Jul  1, 2021U.S. FDA Accepts Filing of Hutchmed’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Dec 28, 2020Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Nov 25, 2019Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors

Further information

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