Metastatic disease occurs in almost 70% of colorectal cancer patients. Credit: mi_viri/Shutterstock.

Health Canada has granted market authorisation to Takeda Canada for FRUZAQLA (fruquintinib) capsules to treat adults with metastatic colorectal cancer (mCRC).

The authorisation is intended for patients who have exhausted certain standard therapies or are not suitable candidates for such treatments.

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These include chemotherapy based on oxaliplatin, irinotecan and fluoropyrimidine along with an anti-vascular endothelial growth factor (VEGF) agent, an anti-epidermal growth factor receptor agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.

The authorisation follows positive reimbursement recommendations from Canada’s Drug Agency (CDA-AMC) and the Institut National D’excellence En Santé et Services Sociaux (INESSS).

It is supported by outcomes from two significant Phase III trials, FRESCO-2, which was multi-regional, and the FRESCO trial in China.

Both trials showed that the capsules with supportive care improved overall survival and progression-free survival compared to placebo.

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As an oral inhibitor of VEGF receptor (VEGFR)-1, -2 and -3, the therapy functions by blocking the formation of new blood vessels in tumours, decelerating cancer growth.

Takeda Canada operates as the Canadian division of Takeda Pharmaceutical Company.

Colorectal Cancer Canada CEO and president Barry Stein stated: “We welcome Health Canada’s authorisation of FRUZAQLA. Knowing that there is a new therapy available will provide hope to patients and their families who have been waiting for new therapeutic options.

“The new treatment provides an additional opportunity for Canadians with metastatic colorectal cancer to slow disease progression.”

Metastatic disease occurs in almost 70% of colorectal cancer patients, either at diagnosis or post-treatment, and is the primary cause of mortality.

In September 2024, Takeda secured approval for the 1mg/5mg dosages of the capsules from the Japanese Ministry of Health, Labour and Welfare for treating unresectable advanced or recurrent colorectal cancer.