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Takeda (NYSE:TAK) has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of fruquintinib, a targeted therapy for previously treated metastatic colorectal cancer (mCRC). If approved by the European Commission, fruquintinib will be a novel treatment in the EU, highlighting its status as the first therapy to inhibit all three vascular endothelial growth factor receptors (VEGFR-1, -2, -3) for mCRC in over a decade. The therapy showed significant improvements in overall survival and progression-free survival in Phase 3 FRESCO-2 trials compared to the current standard care.
Fruquintinib's potential impacts are substantial, offering a new chemotherapy-free option that improves patient outcomes. It has already been approved in the U.S. under the brand name FRUZAQLA® as of November 2023, and launched in China in 2018 as ELUNATE®. Key safety information includes risks such as hypertension, hemorrhagic events, infections, and hepatotoxicity among others.