AUS
NZ
UK
CA
USA
IND
HUTCHMED (China) Limited (“HUTCHMED”) has announced a significant milestone in cancer treatment with its partner Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) receiving approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to manufacture and market FRUZAQLA® (fruquintinib) for previously treated metastatic colorectal cancer (CRC). This marks a landmark moment as FRUZAQLA® becomes the first novel targeted therapy approved in Japan for metastatic CRC, irrespective of biomarker status, in over a decade.
Colorectal cancer is the most common cancer type in Japan, with the National Cancer Center projecting around 161,000 new cases and 54,000 deaths in 2023 alone. FRUZAQLA® is specifically indicated for advanced or recurrent CRC that is neither curable nor resectable and has progressed after chemotherapy, addressing a critical need for effective treatment options in a challenging patient population.
Dr. Weiguo Su, CEO and Chief Scientific Officer of HUTCHMED, expressed optimism about the approval, emphasizing the robustness of the global data package supporting the drug's efficacy. He stated, “Takeda has now obtained approval in Japan for FRUZAQLA®, demonstrating the strength of our global data package and the potential of this novel medicine to provide a much-needed treatment option to patients with metastatic CRC.” Takeda's long-standing expertise in metastatic CRC treatment positions it well to make FRUZAQLA® accessible to patients in Japan.
The significance of this approval is echoed by Dr. Takayuki Yoshino, Deputy Director at the National Cancer Center Hospital East in Japan. He noted, “The approval of FRUZAQLA® in Japan is significant news for patients with metastatic colorectal cancer, who have long needed additional effective treatment options.” Dr. Yoshino highlighted the positive impact of the global FRESCO-2 study, which demonstrated the drug's clinical benefits, and expressed hope that FRUZAQLA® will provide renewed optimism for patients facing this challenging diagnosis.
The MHLW's approval of FRUZAQLA® is based on results from the Phase III FRESCO-2 trial conducted across multiple regions, including the US, Europe, Japan, and Australia. These pivotal results were published in The Lancet in June 2023. Takeda holds the exclusive worldwide rights to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau, with previous approvals granted in the US in November 2023 and in Europe in June 2024.
This advancement highlights the ongoing commitment to improving treatment options for CRC patients and reflects the collaborative efforts of HUTCHMED and Takeda in bringing innovative therapies to market.
