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Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer

Written by Customer Service on . Posted in Public Companies.

LONDON, June 18, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for the development of 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 (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.
Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan (clinicaltrials.gov identifier: NCT04322539).  FRESCO-2 is expected to start enrolling patients in mid-2020.  The U.S. FDA acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study, if positive; the prior positive Phase III 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 (“NDA”) for the treatment of patients with mCRC in the third-line setting.  The adequacy of the data to support a specific indication will be assessed during the review of a New Drug Application.About Fast Track Designation

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