Friday marked the launch of FRUZAQLA® (fruquintinib) in Japan by Takeda (TSE:4502/NYSE:TAK), as announced by HUTCHMED (Nasdaq/AIM:HCM; HKEX:13). This launch follows the approval by the Japanese Ministry of Health, Labour and Welfare in September 2024 for the treatment of metastatic colorectal cancer (CRC). HUTCHMED will receive a milestone payment from Takeda in conjunction with the launch.
FRUZAQLA® is a novel oral targeted therapy and the first of its kind to be approved in Japan for metastatic CRC without regard to biomarker status in over a decade. It is designed for patients with advanced or recurrent CRC that is neither curable nor resectable and has progressed following chemotherapy. Colorectal cancer is a significant health concern in Japan, with an estimated 161,000 new cases and 54,000 deaths in 2023.
The Chief Executive Officer and Chief Scientific Officer of HUTCHMED, Dr. Weiguo Su, expressed the significance of the launch, noting Takeda's strong position to introduce FRUZAQLA® to Japanese patients based on over a decade of leadership in treating metastatic CRC in the country.
FRUZAQLA®'s approval was primarily based on data from the Phase III FRESCO-2 trial conducted in various regions including the US, Europe, Japan, and Australia. The results of this trial were published in The Lancet in June 2023. Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau.
Colorectal cancer is the third most common cancer worldwide, with more than 1.9 million new cases and 900,000 deaths in 2022. The cancer starts in the colon or rectum and can be surgically resected in early stages, but metastatic CRC remains challenging with limited treatment options. Fruquintinib, a selective oral inhibitor of all three VEGF receptors, is designed to inhibit tumor angiogenesis with enhanced selectivity and potential for use in combination therapies.
In mainland China, Hong Kong, and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly (NYSE:LLY) under the brand name ELUNATE®. Since its introduction in China, over 100,000 colorectal cancer patients have been treated with the drug. HUTCHMED, a biopharmaceutical company, is focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases.
The Japan package insert for FRUZAQLA® provides important safety information, including warnings about severe gastrointestinal hemorrhage and gastrointestinal perforation, contraindications for patients with hypersensitivity to any of the ingredients, and various precautions related to the administration of the drug. The full prescribing information for the United States and the European Union Summary of Product Characteristics can be found on the respective websites.
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