Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer
Shots:
- The US FDA has granted priority review to the NDA seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic CRC. The US FDA’s decision for NDA is expected on Nov 2023
- The NDA was based on the P-III multi-regional clinical trial (FRESCO-2) evaluating fruquintinib + BSC vs PBO + BSC in 691 patients across the US, EU, Japan & Australia along with data from the P-III trial (FRESCO). The (FRESCO-2) trial met its 1EPs & 2EPs and showed a clinical improvement in OS & PFS & the therapy was generally well tolerated
- Fruquintinib, a highly selective & potent oral inhibitor of VEGFR -1, -2 & -3. The therapy is currently approved in China under the brand name Elunate
Ref: HUTCHMED | Image: HUTCHMED
Related News:- HUTCHMED Entered into an Exclusive License Agreement with Takeda to Develop and Commercialize Fruquintinib
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