Newsfilterยท2024-04-26 12:30Core Viewpoint - Fruquintinib has received a positive opinion from the CHMP for the treatment of previously treated metastatic colorectal cancer in the EU, potentially making it the first novel targeted therapy for this indication in over a decade [1][2][3] Company Overview - HUTCHMED, in partnership with Takeda, is advancing the development and commercialization of fruquintinib, which has shown significant survival benefits in patients with metastatic colorectal cancer [3][10] - Takeda holds the exclusive worldwide license to develop and market fruquintinib outside of mainland China, Hong Kong, and Macau [2][8] Clinical Trial Insights - The positive CHMP opinion is based on the results from the FRESCO-2 Phase III clinical trial, which demonstrated statistically significant improvements in overall survival and progression-free survival for patients treated with fruquintinib [5][6][8] - FRESCO-2 trial included patients from multiple regions, including the U.S., Europe, Japan, and Australia, and met all primary and key secondary endpoints [5][6] Market Context - Colorectal cancer (CRC) is a significant health issue, being the third most prevalent cancer globally, with over 935,000 deaths in 2020 [4] - In Europe, CRC was the second most common cancer in 2020, with approximately 520,000 new cases and 245,000 deaths [4] Product Information - Fruquintinib is a selective oral inhibitor of VEGFR-1, -2, and -3, designed to inhibit tumor angiogenesis with a manageable safety profile [7][8] - The drug has been approved in the U.S. under the brand name FRUZAQLA, based on data from two large Phase III trials involving a total of 734 patients [8][9]