FDA grants priority review of NDA for Takeda and HUTCHMED’s fruquintinib

Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer.  The Prescription Drug User Fee Act goal date for the FDA’s decision is set for 30 November 2023.  The NDA submission includes data from the Phase 3 FRESCO-2 trial, which demonstrated significant improvements in overall survival and progression-free survival.  Fruquintinib is currently approved in China under the brand name ELUNATE®.