Takeda has launched Fruzaqla (fruquintinib) in Japan for patients with previously treated metastatic colorectal cancer (CRC), following its approval by the Japanese Ministry of Health, Labour and Welfare in September 2024. This launch triggers a milestone payment to HUTCHMED, the originator of fruquintinib. Fruzaqla represents a significant advancement as the first novel oral targeted therapy approved in Japan for metastatic CRC in over a decade, irrespective of biomarker status.
Clinical Significance
Fruzaqla is indicated for advanced or recurrent colorectal cancer that is neither curable nor resectable and has progressed after chemotherapy. Colorectal cancer is highly prevalent in Japan, with approximately 161,000 new cases and 54,000 deaths estimated in 2023, according to the National Cancer Center statistics. The introduction of Fruzaqla offers a much-needed treatment option for patients facing limited alternatives.
Dr. Weiguo Su, CEO and CSO of HUTCHMED, stated, "The launch of FRUZAQLA® in Japan highlights the continued progress of our partnership with Takeda across the globe. Takeda is well positioned to build on more than a decade of leadership in the treatment of metastatic CRC in Japan and bring a differentiated treatment option in FRUZAQLA® to patients."
Regulatory and Clinical Data
The approval of Fruzaqla in Japan was primarily based on the results of the Phase III FRESCO-2 trial, conducted across the US, Europe, Japan, and Australia. The data, published in The Lancet in June 2023, demonstrated consistent benefits in patients treated with fruquintinib. Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau.
Fruzaqla has already received approval in several regions, including the United States (November 2023), the European Union (June 2024), Switzerland (August 2024), Canada, Japan, the United Kingdom (September 2024), Argentina, Australia, and Singapore (October 2024). Regulatory applications are ongoing in numerous other jurisdictions.
About Fruquintinib
Fruquintinib is a highly selective oral inhibitor targeting all three VEGF receptors (VEGFR-1, -2, and -3). By inhibiting these receptors, fruquintinib plays a crucial role in blocking tumor angiogenesis. Its design enhances selectivity, limiting off-target kinase activity, which allows for sustained target inhibition and potential use in combination therapies.
Colorectal Cancer Landscape
Colorectal cancer is a significant global health concern. Worldwide, it is the third most prevalent cancer, with over 1.9 million new cases and 900,000 deaths in 2022, according to the International Agency for Research on Cancer/World Health Organization. In Japan, CRC was the most common cancer in 2022, with approximately 146,000 new cases and 60,000 deaths. While early-stage CRC can be surgically resected, metastatic CRC remains a high unmet need with poor outcomes and limited treatment options.
