Chi-Med’s fruquintinib Fast Track’d for colorectal cancer

The FDA has granted Fast Track Designation for the development of Hutchison China MediTech’s (NASDAQ:HCM) fruquintinib, for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor therapy.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in U.S., Europe and Japan.  patient enrollment is expected to begin in mid-2020.

HCM retains all rights to fruquintinib outside of China and is partnered with Eli Lilly in China.

https://seekingalpha.com/news/3584023-chi-meds-fruquintinib-fast-trackd-for-colorectal-cancer