Health Canada has provided market authorization for Takeda Canada’s FRUZAQLA (fruquintinib capsules), indicated 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, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
This was followed by positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) and Institut national d’excellence en santé et services sociaux (INESSS).
FRUZAQLA works by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer.
The authorization is based on data from two large Phase 3 trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA. In both trials, FRUZAQLA plus best supportive care demonstrated significant improvements in overall survival, with corresponding improvements in progression free survival, versus placebo plus best supportive care.
An estimated 25,200 Canadians will be diagnosed with colorectal cancer in 2024, representing 10 per cent of all new cancer cases. It is the second leading cause of death from cancer in men and the third leading cause of death from cancer in women. Approximately 70 per cent of patients with colorectal cancer will experience metastatic disease, whether at diagnosis or after treatment. Metastases are the main cause of CRC-related mortality.
Barry D. Stein, President and CEO of Colorectal Cancer Canada, said: “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.”
