> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Colorectal Cancer NDA Gets Priority Review
- URL: https://www.fdaweb.com/colorectal-cancer-nda-gets-priority-review/
- Published: 2023-05-26T12:00:00.000Z
- Updated: 2026-09-14T18:34:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154558

FDA has accepted for priority review a Takeda and Hutchmed NDA for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for treating adult patients with previously treated metastatic colorectal cancer (CRC). If approved, the companies say fruquintinib will be the first highly selective inhibitor of all three VEGF receptors approved in the U.S. for this patient population. The agency has set a user fee review action target date of 11/30.

The submission is based on data from the global Phase 3 multi-regional clinical trial FRESCO-2 conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with refractory metastatic CRC.

The study, according to the companies, demonstrated that treatment with fruquintinib resulted in a statistically significant increase in the primary overall survival (OS) endpoint and the key secondary progression-free survival (PFS) endpoint compared to placebo. The median OS was 7.4 months for the 461 patients treated with fruquintinib compared to 4.8 months for the 230 patients in the placebo group, they say. The median PFS was 3.7 months for patients treated with fruquintinib compared to 1.8 months for patients on placebo.

Earlier this year, Hutchmed and Takeda entered into an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside China. In China, fruquintinib is approved under the brand name Elunate, which is marketed under a partnership between Hutchmed and Eli Lilly.