Takeda Wins Approval For New Colorectal Cancer Drug FRUZAQLA In Japan

Takeda  announced today that it has secured approval from Japan’s Ministry of Health, Labour and Welfare to produce and market FRUZAQLA Capsules (1mg/5mg), known generically as fruquintinib. This selective oral inhibitor targets vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. It is indicated for the treatment of advanced or recurrent colorectal cancer (CRC) that cannot be cured or surgically removed and has progressed following chemotherapy.

The approval stems largely from the outcomes of the FRESCO-2 study, a global Phase 3 clinical trial carried out across the U.S., Europe, Japan, and Australia. This trial evaluated the effectiveness of FRUZAQLA combined with best supportive care (BSC) against a placebo plus BSC in patients with metastatic colorectal cancer (mCRC) who had undergone previous treatments. The results showed that FRUZAQLA met all the main and secondary efficacy goals, delivering consistent benefits regardless of prior therapies the patients received. FRUZAQLA also exhibited a tolerable safety profile, with 21% of patients in the placebo group discontinuing due to adverse events, compared to 20% in the FRUZAQLA group. These findings were published in The Lancet in June 2023.

Dr. Takayuki Yoshino, who holds multiple key positions at the National Cancer Center Hospital East—including deputy director, head of the Division for Drug and Diagnostic Development Promotion, and chief of the Department of Gastrointestinal Oncology—played a pivotal role on the Steering Committee for the FRESCO-2 study, stated “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.”

Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, said “For more than a decade, Takeda has been a leader in advancing the treatment of metastatic colorectal cancer in Japan. With this approval of FRUZAQLA, we are able to further support patients living with this debilitating disease. FRUZAQLA is now approved in the U.S., European Union, Japan and a number of other countries around the world, and we remain committed to bringing this treatment to additional patients with metastatic colorectal cancer around the world who urgently need new therapeutic options.”