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).

The approval positions the treatment as a new option for CRC that has progressed following chemotherapy.

The latest approval is based on the outcomes of the international Phase III FRESCO-2 trial.

Conducted across multiple regions, including the US, Europe, Japan and Australia, the study assessed FRUZAQLA plus best supportive care (BSC) compared to placebo plus BSC.

The trial also met all primary and key secondary endpoints.

FRUZAQLA was demonstrated to significantly improve both overall survival and progression-free survival in trial subjects.

The asset’s safety profile was in line with those observed in previous fruquintinib monotherapy studies.

It is an oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2, and -3, and offers enhanced selectivity that limits off-target kinase activity, allowing for sustained target inhibition and potential use in combination therapies.

Takeda holds the sole global licence for the development, commercialisation, and manufacturing of fruquintinib outside of mainland China, Hong Kong and Macau.

The asset received approval from the US Food and Drug Administration (FDA) in November 2023 and from the European Commission in June 2024.

Fruquintinib is marketed and developed by Hutchmed in China.

Takeda global oncology business unit president Teresa Bitetti stated: “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 US, 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.”

The latest development comes after the company received approval from the UK Medicines and Healthcare products Regulatory Agency of fruquintinib for metastatic colorectal cancer.