Takeda (TSE:4502/NYSE) has announced that the Japanese Ministry of Health, Labour and Welfare has approved the manufacture and marketing of FRUZAQLA Capsules (1mg/5mg), containing fruquintinib, a selective oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. This medication is intended for patients with advanced or recurrent colorectal cancer (CRC) that is non-curable or non-resectable and has progressed following chemotherapy.
The approval is largely based on data from the FRESCO-2 trial, a global Phase 3 clinical study conducted in the United States, Europe, Japan, and Australia. This trial compared the efficacy of FRUZAQLA combined with best supportive care (BSC) against a placebo plus BSC in individuals with previously treated metastatic colorectal cancer (mCRC). The FRESCO-2 trial successfully met all primary and key secondary efficacy endpoints, demonstrating significant benefits for patients who received FRUZAQLA, irrespective of their prior therapies. The safety profile of FRUZAQLA was found to be manageable, with 21% of patients in the placebo group discontinuing due to adverse events, compared to 20% in the FRUZAQLA group. Findings from the FRESCO-2 trial were published in The Lancet in June 2023.
Dr. Takayuki Yoshino, deputy director of the hospital and chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who participated in the FRESCO-2 study Steering Committee, commented, “Despite recent advancements in screening and treatment reducing the mortality rate of colorectal cancer, the 5-year survival rate for metastatic colorectal cancer remains low. The approval of FRUZAQLA in Japan brings new hope for patients, their families, and healthcare professionals involved in colorectal cancer treatment. This is of significant clinical importance.”
Teresa Bitetti, president of Takeda’s Global Oncology Business Unit, stated, “For over a decade, Takeda has been at the forefront of improving treatment for metastatic colorectal cancer in Japan. The approval of FRUZAQLA allows us to further support patients facing this challenging disease. FRUZAQLA is now approved in the U.S., European Union, Japan, and several other countries, and we remain dedicated to providing this important treatment option to more patients worldwide who urgently need new therapies.
