HUTCHMED (China) has completed the new drug application (NDA) rolling submission to the US Food and Drug Administration (FDA) for fruquintinib to treat refractory metastatic colorectal cancer (CRC).
The highly selective, potent oral VEGFR-1, -2 and -3 inhibitor fruquintinib has been designed for improving the selectivity of kinase to increase tolerability, minimise off-target toxicities and offer more consistent target coverage.
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The company’s NDA submission is supported by data obtained from the global Phase III FRESCO-2 trial and the Phase III FRESCO trial, which was carried out in China.
Conducted in Japan, Australia, the US, and Europe, the Phase III FRESCO-2 multi-regional clinical trial (MRCT) was designed to assess fruquintinib, along with best supportive care (BSC) against placebo and BSC in refractory metastatic CRC patients.
The findings showed that fruquintinib treatment reduced the risk of death by 34%.
Additionally, the company intends to submit an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in 2023.
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By GlobalDataHUTCHMED chief medical officer and research and development head Dr Michael Shi said: “This FDA submission is a significant milestone for patients in the US with metastatic CRC, one of the most common and deadly cancers in the US and worldwide.
“Fruquintinib is an important treatment option for patients with metastatic CRC in China, where it has been available to patients since 2018.
“We look forward to working with our partner Takeda to commercialise fruquintinib outside China, and we remain on track to submit regulatory filings in Europe and Japan later this year.”
In January this year, HUTCHMED and the Takeda Pharmaceutical Company entered an exclusive licence agreement to develop and commercialise fruquintinib outside mainland China, Macau and Hong Kong.
