Takeda Secures Japanese Approval to manufacture Fruzaqla

Takeda has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) to produce and sell Fruzaqla capsules 1mg/5mg (fruquintinib), an oral inhibitor of VEGFR-1, -2, and -3, for advanced or recurring colorectal cancer treatment that has failed chemotherapy and cannot be cured or removed.

The endorsement is primarily supported by the findings of the FRESCO-2 study, an international phase 3 clinical trial carried out in the United States, Europe, Japan, and Australia. The study evaluated the effectiveness of Fruzaqla combined with best supportive care (BSC) versus a placebo combined with BSC in patients who had already received treatment for metastatic colorectal cancer (mCRC). The FRESCO-2 study achieved success in meeting all main and important secondary effectiveness measures and showed uniform advantages in individuals treated with Fruzaqla, regardless of their prior therapies.

Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, “Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need. The approval of Fruzaqla in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance.”