Takeda, a Japanese pharma company, bought the rights - with an exclusive worldwide license – to further develop, commercialize and manufacture fruquintinib outside of China in January this year (2023). It has now submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLF) in Japan for its approval of the drug that treats adult patients with previously treated metastatic colorectal cancer (CRC).
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors -1, -2, and -3 that play a vital role in blocking tumor angiogenesis. CRC has the highest incidence and second highest mortality rate among both women and men in Japan.
The NDA for fruquintinib is based on results from FRESCO-2, a global phase 3 multi-regional clinical trial (MRCT) conducted in the US, Europe, Japan and Australia, as well as data from the phase 3 FRESCO clinical trial conducted in China.
Fruquintinib well tolerated by patients
The clinical trials compared fruquintinib plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic CRC. Both trials met their primary and key secondary endpoints, showing a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS). Fruquintinib has been generally well tolerated by patients.
Michael Shi, head of R&D and chief medical officer of Hutchmed, said: “Alongside our partner Takeda, we are pleased to take this key step towards bringing fruquintinib to patients in Japan.
“Supported by a strong clinical data set, and its success in China, we believe that fruquintinib is an important option for these patients and are optimistic about the impact it will have if approved in Japan. There is now real regulatory momentum behind fruquintinib, and we are excited to see this drug take to the global stage.”
This is the third submission after theUS Food and Drug Administration (FDA) granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. The FDA is also inspecting Hutchmed’s manufacturing facility in Suzhou, China that has been completed.
In Europe, a marketing authorization application (MAA) to the European Medicine Association (EMA) was validated and accepted for regulatory review in June this year (2023).
Cancer starting in colon or rectum
Fruquintinib is developed and marketed in China by Hutchmed, 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, JAMA.
CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020. In the US, it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.
In its research, Hutchmed found that in Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, it found CRC was the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.