Pharma Focus Asia

Takeda and HUTCHMED Announce FDA New Drug Application (NDA) for Fruquintinib

Friday, May 26, 2023

Takeda and HUTCHMED announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colourectal cancer (CRC).

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumour angiogenesis. Fruquintinib is designed to improve kinase selectivity with the intention of minimising off-target toxicities, improving tolerability and providing more consistent target coverage.

There are significant needs for patients with this disease in the U.S., and fruquintinib has the potential to address these needs regardless of patients’ biomarker status. If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.

The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialisation in China. This acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colourectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients.

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