Health Canada approves FRUZAQLA for metastatic colorectal cancer treatment

CANADA—Health Canada has granted approval for Takeda Canada’s FRUZAQLA (fruquintinib) capsules to be used in the treatment of adults with metastatic colorectal cancer (mCRC).

This marks a significant milestone for patients who have run out of other treatment options or are not suitable candidates for conventional therapies.

The approval comes after a thorough evaluation by Health Canada, and it targets individuals who have already undergone chemotherapy involving oxaliplatin, irinotecan, and fluoropyrimidine, along with other treatments such as anti-vascular endothelial growth factor (VEGF) agents, anti-epidermal growth factor receptor agents (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.

The approval is based on positive feedback from both the Canada’s Drug Agency (CDA-AMC) and the Institut National D’excellence En Santé et Services Sociaux (INESSS).

It is also supported by the results of two significant Phase III clinical trials: FRESCO-2, a multi-regional trial, and the FRESCO trial conducted in China.

Both trials demonstrated that when combined with supportive care, FRUZAQLA significantly improved overall survival and progression-free survival rates compared to a placebo.

FRUZAQLA is an oral treatment that works by inhibiting VEGF receptors (VEGFR)-1, -2, and -3.

These receptors play a critical role in the formation of new blood vessels, which tumours rely on for growth.

By blocking these receptors, FRUZAQLA helps slow down the progression of cancer by restricting the tumour’s blood supply.

Takeda Canada, the Canadian division of Takeda Pharmaceutical Company, is committed to improving treatment options for cancer patients.

Barry Stein, CEO and president of Colorectal Cancer Canada, expressed his support for Health Canada’s decision, highlighting the hope this new therapy brings to patients and their families.

“Knowing that there is a new therapy available provides hope to those who have been waiting for new options to manage their condition,” Stein said.

He emphasized that this treatment provides an additional tool for patients with metastatic colorectal cancer to manage and slow the progression of the disease.

Nearly 70% of colorectal cancer patients develop metastatic disease, either at diagnosis or following treatment, and this stage of cancer is the leading cause of death among these patients.

In addition to the approval in Canada, Takeda also received approval for the 1 mg/5 mg dosages of FRUZAQLA from Japan’s Ministry of Health, Labour, and Welfare in September 2024 to treat advanced or recurrent colorectal cancer that cannot be surgically removed. 

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