Takeda and Hutchmed announced today (May 26) that the FDA has granted the priority review of the New Drug Application (NDA) for fruquintinib which is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2 and 3 for the treatment of adults with previously treated CRC.
If approval is granted, the drug will be the first of its kind approved in the US for the disease. The Prescription Drug User Fee Act (PDUFA) goal date the FDA has granted is November, 30, of this year (2023).
“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallahhead of global medical affairs oncology at Takeda.
“There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”
The NDA for fruquintinib includes results from the phase 3 Fresco-2 trial along with data from the phase 3 Fresco trial conducted in China.
Fresco-2 is clinical trial (MRCT) conducted in the US, Europe, Japan and Australia investigating fruquintinib with best supportive care (BSC) against 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.
Michael Shi, head of R&D and chief medical officer, Hutchmed, said: “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China. We are pleased to have Takeda as our partner furthering development and commercialization of fruquintinib outside of China.
“Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally.”
Fruquintinib is currently approved in China under the brand name Elunate. Approval in China was based on the results of the Fresco study, a phase 3 pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, published in The Journal of the American Medical Association, in June 2018.
In March 2023, Hutchmed and Takeda closed an exclusive licensing agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.
