China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC). This submission marks a significant step in making the treatment available to patients in Japan.
Fruquintinib’s Mechanism of Action and Clinical Trials
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, which are crucial in blocking tumor angiogenesis. The NDA submission is supported by the results from FRESCO-2, a global Phase III multi-regional clinical trial conducted in the US, Europe, Japan, and Australia, along with data from the Phase III FRESCO clinical trial conducted in China. Both trials compared fruquintinib plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic CRC, meeting their primary and key secondary endpoints, showing statistically significant improvements in overall survival (OS) and progression-free survival (PFS). Fruquintinib has demonstrated good tolerability in patients.
Regulatory Progress in the US and Europe
The submission in Japan follows prior submissions for fruquintinib in the US and Europe for the same indication. The US FDA has granted Priority Review status to the molecule and set a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. The FDA review is underway, and the inspection of HutchMed’s manufacturing facility in Suzhou, China, has been completed. In Europe, a Marketing Authorization Application (MAA) was validated and accepted for regulatory review by the European Medicines Agency (EMA) in June 2023.
Conclusion
The NDA submission for fruquintinib in Japan is a testament to HutchMed’s commitment to expanding access to innovative cancer treatments. With positive clinical trial results and ongoing regulatory reviews in the US and Europe, fruquintinib has the potential to become a standard of care for patients with metastatic CRC worldwide.-Fineline Info & Tech
