HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and irinotecan, as well as standard treatments such as anti-vascular endothelial growth factor (VEGF) therapy, anti-epidermal growth factor receptor (EGFR) therapy, and trifluridine, tipiracil, or regorafenib.
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which are instrumental in inhibiting tumor angiogenesis. The drug was approved for marketing by China’s National Medical Products Administration (NMPA) in September 2018 and was commercially launched in China in November of the same year for the treatment of metastatic colorectal cancer (mCRC) in patients who had previously been treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who had previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). In March 2023, HutchMed entered into a USD 1.13 billion licensing agreement with Takeda, granting Takeda development, commercialization, and manufacturing rights for the drug worldwide, excluding mainland China, Hong Kong, and Macau. The drug was approved in the U.S. in November 2023 under the trade name Fruzaqla for the treatment of pre-treated mCRC. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the drug for the aforementioned indication in April of this year.- Flcube.com
