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(Sharecast News) - Hutchmed China, in collaboration with Takeda, announced on Friday that the US Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) of fruquintinib.
The AIM-traded company described fruquintinib as a potent and highly-selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, intended for the treatment of adult patients with previously-treated metastatic colorectal cancer (CRC).
If approved, it would become the first and only highly-selective inhibitor of all three VEGF receptors to be approved in the US for that indication.
The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for the NDA was 30 November 2023.
Hutchmed said the NDA included data from the phase three 'FRESCO-2' trial and the phase three 'FRESCO' trial conducted in China.
The FRESCO-2 trial, a global phase three multi-regional clinical trial, involved participants from the US, Europe, Japan, and Australia.
It said the trial evaluated fruquintinib in combination with best supportive care (BSC), versus placebo with BSC, among patients with previously-treated metastatic CRC.
The trial successfully achieved its primary and key secondary endpoints, demonstrating a significant and clinically-meaningful improvement in overall survival (OS) and progression-free survival (PFS), respectively.
Patients enrolled in the trials generally tolerated fruquintinib well, the company added.
Fruquintinib, marketed as 'Elunate', was already approved in China, based on the positive outcomes of the FRESCO study - a phase three pivotal registration trial involving 416 patients with metastatic CRC in China.
The trial results were published in the Journal of the American Medical Association (JAMA) in June 2018.
In March of this year, Hutchmed China and Takeda entered into an exclusive licensing agreement to expand the global development, commercialisation and manufacturing of fruquintinib outside China.
"The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialisation in China," said Dr Michael Shi, head of research and development and chief medical officer at Hutchmed.
"We are pleased to have Takeda as our partner furthering development and commercialisation of fruquintinib outside of China."
Dr Shi said the acceptance marked a "significant advancement" towards providing patients with previously-treated metastatic colorectal cancer a "much-needed" therapeutic option, given the limited treatment options currently available.
"This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally."
At 1109 BST, shares in Hutchmed China were up 6.01% at 217.85p.
Reporting by Josh White for Sharecast.com.
