Takeda’s FRUZAQLA approved in Japan for advanced colorectal cancer

Takeda has achieved a significant milestone with the Japanese Ministry of Health, Labour and Welfare (MHLW) granting approval for its FRUZAQLA capsules (fruquintinib) at dosages of 1mg and 5mg. This medication is designed to treat unresectable advanced or recurrent colorectal cancer (CRC) that has persisted despite chemotherapy treatments.

This approval introduces a novel therapeutic option for patients with CRC, providing hope for those who have not responded to existing chemotherapy regimens. The decision by the MHLW was influenced by the results of the international Phase III FRESCO-2 trial. This extensive study was conducted in several regions, including the United States, Europe, Japan, and Australia.

The FRESCO-2 trial aimed to evaluate the efficacy of FRUZAQLA combined with the best supportive care (BSC), as opposed to a placebo combined with BSC. The trial successfully met all its primary and key secondary endpoints, demonstrating FRUZAQLA's effectiveness.

As an oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, FRUZAQLA has shown to significantly improve both overall survival and progression-free survival among trial participants. The safety profile of FRUZAQLA was consistent with results from earlier studies involving fruquintinib monotherapy. Its selectivity in inhibiting VEGFR limits off-target kinase activity, which means it provides sustained target inhibition and may be suitable for combination therapies.

Takeda holds the exclusive global license for the development, commercialization, and manufacturing of fruquintinib outside of mainland China, Hong Kong, and Macau. In November 2023, fruquintinib secured approval from the U.S. Food and Drug Administration (FDA), followed by the European Commission’s approval in June 2024. Within China, Hutchmed is responsible for the marketing and development of fruquintinib.

Teresa Bitetti, President of Takeda's Global Oncology Business Unit, expressed the company's long-standing commitment to improving treatments for metastatic colorectal cancer in Japan. She highlighted that with the approval of FRUZAQLA, Takeda continues to support patients battling this challenging disease. FRUZAQLA is now approved in the US, the European Union, Japan, and various other countries. Takeda remains dedicated to making this treatment accessible to more patients worldwide who are in dire need of new therapeutic options.