By Josh White
Date: Thursday 18 Jun 2020
LONDON (ShareCast) - (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.
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Currency | UK Pounds |
Share Price | 295.00p |
Change Today | -3.00p |
% Change | -1.01 % |
52 Week High | 352.00 |
52 Week Low | 173.60 |
Volume | 233 |
Shares Issued | 871.26m |
Market Cap | £2,570.23m |
RiskGrade | 226 |
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No dividends found |
Time | Volume / Share Price |
16:27 | 65 @ 296.97p |
15:30 | 1 @ 294.00p |
15:29 | 26 @ 294.00p |
15:29 | 1 @ 294.00p |
15:23 | 84 @ 296.97p |
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