(Sharecast News) - Hutchison China MediTech, trading as 'Chi-Med', announced on Thursday that the US Food and Drug Administration (FDA) has granted 'fast track designation' for the development of 'fruquintinib'.
The AIM-traded firm explained that it was 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 (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.
It said it was initiating a phase 3 registration study, known as the 'FRESCO-2' study, in refractory mCRC in the United States, Europe and Japan.
FRESCO-2 was expected to start enrolling patients in mid-2020.
"The FDA acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study, if positive; the prior positive phase 3 FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for mCRC in China in 2018; and additional completed and ongoing supporting studies in mCRC could support a new drug application for the treatment of patients with mCRC in the third-line setting," Chi-Med's board said in its statement.
"The adequacy of the data to support a specific indication will be assessed during the review of a new drug application."
At the close on Thursday, shares in Hutchison China MediTech were up 2.78% at 370p.
Hutchmed (HCM)3 May 2024 13:37