Health Canada recently granted market authorization to Takeda Canada for FRUZAQLA (fruquintinib) capsules, a new treatment option for adults with metastatic colorectal cancer (mCRC). This approval offers a significant advancement for patients who have exhausted standard therapies or are ineligible for existing treatments. Specifically, it targets patients previously treated with chemotherapy regimens including oxaliplatin, irinotecan, and fluoropyrimidine, in combination with an anti-VEGF agent and an anti-EGFR agent (if RAS wild-type), and subsequently treated with either trifluridine-tipiracil or regorafenib.
Table Content:
Positive Recommendations and Clinical Trial Success
This decision follows positive reimbursement recommendations from the Canadian Drug Agency (CDA-AMC) and the Institut National D’excellence En Santé et Services Sociaux (INESSS). The approval is substantiated by promising results from two pivotal Phase III clinical trials: the multi-regional FRESCO-2 trial and the FRESCO trial conducted in China. Both trials demonstrated that FRUZAQLA, in conjunction with supportive care, significantly improved overall survival and progression-free survival compared to placebo.
Targeting Tumor Growth with VEGFR Inhibition
FRUZAQLA is an oral inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. By blocking these receptors, the therapy inhibits the formation of new blood vessels within tumors, effectively slowing cancer growth and progression. This mechanism of action offers a targeted approach to combating mCRC. Takeda Canada, the Canadian arm of Takeda Pharmaceutical Company, will be responsible for the distribution and marketing of FRUZAQLA.
Addressing an Unmet Need in mCRC
Barry Stein, CEO and President of Colorectal Cancer Canada, welcomed the approval, emphasizing the hope it provides to patients and families seeking new treatment options. He highlighted that FRUZAQLA offers an additional opportunity for Canadians with mCRC to slow disease progression, addressing a significant unmet need in the cancer community. Metastatic disease affects nearly 70% of colorectal cancer patients, either at the time of diagnosis or following initial treatment, and is the leading cause of mortality in this patient population.
Global Expansion of Fruquintinib Access
This approval in Canada follows recent regulatory success for FRUZAQLA in other regions. In September 2024, Takeda obtained approval from the Japanese Ministry of Health, Labour and Welfare for 1mg/5mg dosages of FRUZAQLA for the treatment of unresectable advanced or recurrent colorectal cancer. This highlights the growing global recognition of FRUZAQLA’s potential in addressing the challenges of advanced colorectal cancer. The availability of FRUZAQLA in Canada signifies a crucial step forward in the fight against mCRC, offering new hope for patients battling this aggressive disease.
Conclusion
The approval of FRUZAQLA by Health Canada represents a major milestone in the treatment landscape for mCRC. The drug’s unique mechanism of action and proven efficacy in clinical trials offer a new and promising option for patients who have limited treatment alternatives. This development underscores the ongoing commitment to advancing cancer care and improving outcomes for individuals affected by this devastating disease.
