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.