Surufatinib Earns Fast-Track Designation
The FDA granted Chi-Med’s surufatinib Fast-Track designation for treatment of two forms of neuroendocrine tumors (NET).
The designation was for advanced and progressive pancreatic NET and for non-pancreatic NET in patients who would not respond to surgery.
The agency granted surufatinib an Orphan Drug designation for pancreatic NET in November 2019.
Chi-Med is preparing for regulatory review in the U.S., Europe and Japan, based on data from two positive phase 3 trials of the drug in China and an ongoing trial in the U.S.