Takeda Pharmaceuticals, a global life sciences company headquartered in Tokyo, announced in a press release that its fruquintinib medication has been approved by the Japanese Ministry of Health, Labour and Welfare. Marketed as Fruzaqla, the drug has been approved for use in unresectable advanced or recurrent colorectal cancer.
Dr. Takayuki Yoshino, who served on the steering committee for the the FRESCO-2, which examined fruquintinib’s effectiveness in studies across the United States, Europe, Japan and Australia, said that new treatment options for colorectal cancer are a much-needed addition.
“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.” — Dr. Takayuki Yoshino, via press release.
The press release announcement from Takeda is available below, or can be accessed here at Takeda.com.
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September 24, 2024 – OSAKA, Japan and CAMBRIDGE, Massachusetts, September 24, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.
The approval is based primarily on the results of the FRESCO-2 trial, a global Phase 3 clinical trial conducted in the United States, Europe, Japan and Australia. The trial compared FRUZAQLA plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic colorectal cancer (mCRC). The FRESCO-2 trial met all primary and key secondary efficacy endpoints and demonstrated consistent benefits in patients who received FRUZAQLA, regardless of the types of therapy the patients had previously received. FRUZAQLA demonstrated a manageable safety profile in the FRESCO-2 trial, with the incidence of adverse events leading to discontinuation being 21% in the placebo plus BSC arm compared to 20% in the FRUZAQLA plus BSC arm.1 The data from the FRESCO-2 trial were published in The Lancet in June 2023.
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.”
“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,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “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.”
About FRUZAQLA (fruquintinib)
FRUZAQLA is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLA was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure achieving sustained target inhibition and flexibility for potential use as part of combination therapy.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023 and by the European Commission (EC) in June 2024. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®.
Last modified: September 24, 2024
