▎WuXiEdited by Kant Content Team

Takeda and HUTCHMED Announce CHMP Positive Opinion for Fruzaqla (Fruquintinib) for the Treatment of Adult Patients with Previously Treated Metastatic Colorectal Cancer (mCRC)If approved, fruquintinib will become the first innovative targeted therapy approved in the EU for the treatment of metastatic colorectal cancer in over a decade, regardless of patients' biomarker status.In addition,Fruquintinib will also become the first drug approved in the EU for previously treated mCRC patients that can selectively inhibit all three VEGF receptor subtypes.

The marketing application of Fruquintinib is mainly based on the results of the FRESCO-2 Phase 3 clinical study.FRESCO-2 is a Phase III international multicenter clinical trial (MRCT) conducted in the United States, Europe, Japan, and Australia, aiming to explore the efficacy and safety of fruquintinib combined with best supportive care (BSC) versus placebo combined with BSC for the treatment of pretreated metastatic colorectal cancer patients. The data showed that the study met its primary endpoint and key secondary endpoints.AcceptFruquintinib treatment significantly improved overall survival (OS) and progression-free survival (PFS) with statistical and clinical significance.Moreover, fruquintinib was generally well-tolerated in patients.

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2, and -3. Its design aims to achieve higher kinase selectivity, minimize off-target toxicity, improve tolerability, and provide more consistent target coverage.In March 2023, Takeda and HUTCHMED reached an exclusiveLicense Agreement, to further advance the development, commercialization, and production of fruquintinib globally, excluding mainland China, Hong Kong, and Macao. The drug was previously approved inChinaAndUnited StatesApproved for marketing.

References:

[1] Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer. Retrieved April 26, 2024 from https://www.businesswire.com/news/home/20240425251580/en

[2] HUTCHMED Announces Takeda Receives Positive CHMP Opinion from the European Medicines Agency for Fruquintinib in the Treatment of Previously Treated Metastatic Colorectal Cancer. Retrieved April 26, 2024 from https://www.hutch-med.com/tc/positive-chmp-opinion-for-fruquintinib-in-mcrc/

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