Takeda has launched FRUZAQLA® (fruquintinib) in Japan following its approval by the Japanese Ministry of Health, Labour and Welfare. The drug is indicated for the treatment of advanced or recurrent colorectal cancer (CRC) that has progressed after chemotherapy. This launch marks a significant milestone as the first novel oral targeted therapy approved for metastatic CRC in Japan in over a decade.
Addressing a Critical Unmet Need in Japan
Colorectal cancer is the most prevalent cancer in Japan, with approximately 161,000 new cases and 54,000 deaths estimated in 2023. The introduction of FRUZAQLA® offers a new treatment option for patients with advanced disease who have progressed after standard chemotherapy. Dr. Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, stated, "The launch of FRUZAQLA® in Japan highlights the continued progress of our partnership with Takeda across the globe...to bring a differentiated treatment option in FRUZAQLA® to patients."
Milestone Payment and Global Rights
The launch of FRUZAQLA® triggers a milestone payment to HUTCHMED from Takeda, who holds exclusive worldwide rights to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. Fruquintinib is marketed under the brand name FRUZAQLA®.
Approval Based on FRESCO-2 Trial Data
The approval of FRUZAQLA® in Japan was primarily based on results from the Phase III FRESCO-2 trial, which was conducted in the US, Europe, Japan, and Australia. The data, published in The Lancet in June 2023, demonstrated a statistically significant improvement in overall survival in patients treated with fruquintinib compared to placebo. The global regulatory submissions are based on data from two large, randomized, controlled Phase III trials, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials.
Mechanism of Action and Prior Approvals
Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3), playing a pivotal role in inhibiting tumor angiogenesis. It has been designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. FRUZAQLA® has already been approved in the US (November 2023), the EU (June 2024), Switzerland (August 2024), Canada, Japan, and the United Kingdom (September 2024), as well as in Argentina, Australia, and Singapore (October 2024). Regulatory applications are progressing in many other jurisdictions.
