Cathy Eng: It’s great to see Fruquintinib (FRUZAQLA) approved in Japan for advanced colorectal cancer

Takeda’s FRUZAQLA Approved in Japan for Advanced Colorectal Cancer

Takeda has secured approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its 1mg/5mg FRUZAQLA capsules (fruquintinib) to treat unresectable advanced or recurrent colorectal cancer (CRC) that has progressed following chemotherapy.

The approval is based on the positive results of the international Phase III FRESCO-2 trial, which compared FRUZAQLA plus best supportive care (BSC) to placebo plus BSC in patients with previously treated metastatic colorectal cancer. The trial met all primary and key secondary endpoints, demonstrating significant improvements in overall survival and progression-free survival for patients receiving FRUZAQLA.

FRUZAQLA is an oral inhibitor targeting vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, with enhanced selectivity to minimize off-target kinase activity. This allows for sustained target inhibition and potential use in combination therapies. Takeda holds the exclusive global rights to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau.

FRUZAQLA has also been approved by the U.S. FDA in November 2023 and the European Commission in June 2024.“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,” said Teresa Bitetti, president of the Global Oncology Business Unit at Taked.

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Photo taken from clinicaltrialsarena.com

Cathy Eng shared a post on X regarding the approval of the drug:

“It’s great to see Fruquintinib (FRUZAQLA) approved in the US, EU, China, Macau, and now in Japan for advanced colorectal cancer.”

Cathy Eng is a Professor of Medicine, Hematology and Oncology, and is the Co-Director of GI Oncology and Co-Leader of the Gastrointestinal Cancer Research Program at the Vanderbilt-Ingram Cancer Center. She also holds the David H. Johnson Endowed Chair of Surgical and Medical Oncology.

Dr. Eng was previously a Professor of Medical Oncology at The University of Texas MD Anderson Cancer Center. Her primary clinical research interests include clinical trials involving innovative drugs for the treatment of colorectal, anal, and appendiceal cancers. She has a specific interest in young colorectal cancer patients as well as the role of immunotherapy in HPV-associated cancers. Nationally, Dr. Eng has served in multiple leadership roles for ASCO, ASCO GI, ECOG, and the NCI Rectal/Anal Task Force. She has most recently been chosen to serve as the Vice-Chair for the SWOG GI Committee and the NCI GI Steering Committee.

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