Health Canada has granted market authorization to Takeda Canada's Fruzaqla (fruquintinib) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available standard therapies. This includes patients who have received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF agents, and anti-EGFR agents (if RAS wild-type), as well as either trifluridine-tipiracil or regorafenib.
The approval is based on data from the Phase 3 FRESCO-2 and FRESCO trials, which demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) compared to placebo plus best supportive care.
Clinical Trial Data
The multi-regional FRESCO-2 trial showed that patients receiving fruquintinib (n = 461) had a median OS of 7.4 months (95% CI, 6.7-8.2) compared to 4.8 months (95% CI, 4.0-5.8) in the placebo group (n = 230), with a hazard ratio of 0.66 (95% CI, 0.55-0.80; P < .0001). The FRESCO trial, conducted in China, reported a median OS of 9.3 months (95% CI, 8.2-10.5) in the fruquintinib arm (n = 278) versus 6.6 months (95% CI, 5.9-8.1) in the placebo arm (n = 138), with a hazard ratio of 0.65 (95% CI, 0.51-0.83; P < .001).
In FRESCO, the median PFS was 3.7 months (95% CI, 3.7-4.6) in the fruquintinib arm vs 1.8 months (95% CI, 1.8-1.8) in the placebo arm (HR, 0.26; 95% CI, 0.21 to 0.34; P < .001).
Safety Profile
In the FRESCO-2 trial, grade 3 or higher adverse events (AEs) were observed in 63% of patients treated with fruquintinib and 50% of those receiving placebo. Common grade 3 or higher AEs in the fruquintinib group included hypertension (14%), asthenia (8%), and hand-foot syndrome (6%).
Mechanism of Action
Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. By inhibiting VEGFRs, fruquintinib blocks tumor angiogenesis, thereby slowing cancer growth.
Impact on mCRC Treatment
Approximately 70% of colorectal cancer patients develop metastatic disease, either at diagnosis or post-treatment, making it the primary cause of mortality related to CRC. The approval of fruquintinib offers a new therapeutic avenue for patients who have exhausted other standard treatments.
Barry D. Stein, President and CEO of Colorectal Cancer Canada, stated, "We welcome Health Canada’s authorization 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. This new treatment provides an additional opportunity for Canadians with metastatic colorectal cancer to slow disease progression."
Dr. Hatim Karachiwala, a medical oncologist at the Tom Baker Cancer Centre in Calgary, Alberta, added, "Fruquintinib represents a new option in the treatment of metastatic colon cancer. This therapy aims to slow disease progression, with the potential to help extend survival."
