HUTCHMED and Takeda are expanding the reach of Fruzaqla (fruquintinib) as a treatment for metastatic colorectal cancer (CRC). Takeda received a national reimbursement recommendation for Fruzaqla in Spain, triggering a $10 million milestone payment to HUTCHMED. Concurrently, Takeda launched Fruzaqla in Japan after receiving approval from the Japanese Ministry of Health, Labour and Welfare in September 2024.
European Reimbursement and Market Access
The national reimbursement recommendation in Spain marks a significant step for Fruzaqla in Europe. Colorectal cancer is the second most common cause of cancer-related deaths in Europe, making this reimbursement a crucial advancement for patient access to a novel treatment option. Dr. Weiguo Su, CEO and CSO of HUTCHMED, stated, "This is an important step forward in improving patient access across Europe more broadly," underscoring the company's commitment to addressing the needs of patients with metastatic CRC.
Launch in Japan
Takeda's launch of Fruzaqla in Japan provides a new treatment option for patients with advanced or recurrent CRC that has progressed after chemotherapy. Fruzaqla is the first novel oral targeted therapy approved in Japan for metastatic CRC, regardless of biomarker status, in over a decade. According to the National Cancer Center, CRC is the most prevalent cancer in Japan, with approximately 161,000 new cases and 54,000 deaths estimated in 2023.
Clinical Basis and Global Approvals
The approvals are based on data from the Phase III FRESCO-2 trial, an international, multicenter, randomized, double-blind study. The results, published in The Lancet in June 2023, demonstrated the efficacy and safety of fruquintinib in patients with refractory metastatic CRC. Fruzaqla has already been approved in the US (November 2023), the EU (June 2024), Switzerland (August 2024), Canada, the United Kingdom (September 2024), Argentina, Australia, and Singapore (October 2024).
About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2, and -3), playing a pivotal role in inhibiting tumor angiogenesis. Its design allows for enhanced selectivity, limiting off-target kinase activity and enabling sustained target inhibition. In mainland China, Hong Kong, and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE® and has been used to treat over 100,000 patients with colorectal cancer since its launch.
Safety Information
Fruzaqla carries warnings and precautions regarding hypertension, hemorrhagic events, gastrointestinal perforation, proteinuria, palmar-plantar erythrodysesthesia syndrome (PPES), posterior reversible encephalopathy syndrome (PRES), impaired wound healing, and arterial and venous thromboembolic events. Concurrent use with strong CYP3A inducers should be avoided, while no dose adjustment is needed with CYP3A inhibitors or gastric acid-lowering agents. Common adverse reactions include thrombocytopenia, hypothyroidism, and hypertension.
