Ontario Approves Reimbursement for Fruzaqla in Metastatic Colorectal Cancer Treatment
Key Insights
Ontario Drug Benefit (search) has approved Fruzaqla (fruquintinib) for reimbursement through the Exceptional Access Program for metastatic colorectal cancer (search) patients who have exhausted standard therapies.
The approval makes Ontario the sixth Canadian province to provide coverage for this VEGFR (search) inhibitor, following Quebec, British Columbia, New Brunswick, Nova Scotia, and Saskatchewan.
Fruzaqla demonstrated significant improvements in overall survival and progression-free survival in two Phase 3 trials, offering hope for patients facing a median survival of five months without treatment options.
Takeda Canada (search) announced that Ontario Drug Benefit (search) (ODB) has included Fruzaqla (fruquintinib capsules) in its list of drugs eligible for funding through the Exceptional Access Program (EAP) for treating adult patients with metastatic colorectal cancer (search) (mCRC) who have been previously treated with, or are not considered candidates for available standard therapies.
The approval addresses a critical unmet need for patients with treatment-resistant metastatic colorectal cancer (search). "When patients with metastatic colorectal cancer become resistant to all currently funded therapies in their province, many will face a grim future as on average, half of these patients do not survive for more than five months," said Dr. Eric Chen, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre.
Clinical Significance and Disease Burden
Metastatic colorectal cancer (search) refers to cancer of the colon that has spread to other parts of the body, such as to the liver or lungs. Colorectal cancer (search) is the third most diagnosed cancer in Ontario, with approximately 70 percent of patients with CRC experiencing metastatic disease, whether at diagnosis or after treatment. Metastases are the main cause of CRC-related death.
Dr. Chen emphasized the potential impact of this new treatment option: "FRUZAQLA gives those living with mCRC an important new treatment option to potentially give them more time to spend with their family and enjoy other life milestones."
Expanding Access Across Canada
Ontario becomes the sixth province to reimburse Fruzaqla, following Quebec, British Columbia, New Brunswick, Nova Scotia, and Saskatchewan. The drug received market authorization by Health Canada in September 2024 and has received positive reimbursement recommendations from Canada's Drug Agency (CDA-AMC) and Institut national d'excellence en santé et services sociaux (INESSS).
"We're pleased that more Canadians living with mCRC now have access to FRUZAQLA, including those in Ontario, the province with the highest number of patients," said Kiran Dharani, Oncology Country Head, Takeda Canada (search). "We remain committed to working with provinces to ensure every patient who can benefit from this treatment has the opportunity to do so."
Mechanism of Action and Clinical Evidence
Fruzaqla is a selective oral inhibitor of vascular endothelial growth factors receptors (search) (VEGFR (search)) -1, -2, and -3 with half maximal inhibitory concentration (IC50) values of 33, 35, and 0.5 nM, respectively. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. The drug works by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer.
The authorization for treating metastatic colorectal cancer (search) 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.