New drug application for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review
Takeda and Hutchmed (China) Limited announced that the FDA has granted priority review of the New Drug Application (“NDA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer
If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.
The NDA for fruquintinib includes results from the Phase III FRESCO-2 trial along with data from the Phase III FRESCO trial conducted in China. FRESCO-2 is a global Phase III multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care vs placebo plus BSC in patients with previously treated metastatic CRC. The FRESCO-2 trial met its primary and key secondary endpoints, showing a significant and clinically meaningful improvement in overall survival and progression-free survival respectively. Fruquintinib has been generally well tolerated in patients to date.
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