Fruquintinib has been developed for the treatment of adults with previously treated metastatic colorectal cancer. Credit: Kateryna Kon via Shutterstock.com.

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib.

Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US for previously treated metastatic colorectal cancer.

It blocks tumour angiogenesis, improves kinase selectivity to minimise off-target toxicities and provides consistent target coverage.

The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials.

The multi-regional clinical trial (MRCT) FRESCO-2 evaluated fruquintinib plus best supportive care (BSC) against placebo plus BSC.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

This 691-patient study was conducted in Europe, the US, Japan and Australia. It met both the primary endpoint of overall survival and the key secondary endpoint of progression-free survival.

HUTCHMED research and development head and chief medical officer Dr Michael Shi stated: “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialisation in China.

“We are pleased to have Takeda as our partner furthering development and the commercialisation 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.”

The FDA has now assigned a prescription drug user fee act action date of 30 November 2023 for the NDA.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines.

Discover the Impact