HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
The CHMP’s recommendation follows the successful outcomes of the Phase III multi-regional FRESCO-2 trial, which met both its primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) with fruquintinib.
Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, playing a crucial role in inhibiting tumor angiogenesis. It was granted marketing approval by the NMPA in September 2018 and was commercially launched in China in November of the same year for the treatment of 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 $1.13 billion licensing agreement with Takeda, which granted Takeda global development, commercialization, and manufacturing rights to the drug, excluding mainland China, Hong Kong, and Macau. Fruquintinib was approved in the U.S. in November 2023 under the trade name Fruzaqla for the treatment of pre-treated mCRC.- Flcube.com
