Ontario Launches FAST Program with Scemblix as First Priority Cancer Therapy for CML Patients
Key Insights
Ontario becomes the first Canadian province to implement the FAST program, fast-tracking public access to breakthrough cancer (search) therapies and reducing patient wait times by nearly a year.
Scemblix (asciminib) is among the first therapies prioritized under this program for newly diagnosed chronic myeloid leukemia (search) patients, following Health Canada approval in July 2025.
The innovative therapy represents the first CML (search) treatment targeting the ABL Myristoyl Pocket (search), offering a novel mechanism of action compared to existing tyrosine kinase inhibitors.
Ontario has launched a groundbreaking initiative to accelerate cancer (search) patient access to innovative therapies, with Novartis' Scemblix (asciminib) becoming one of the first treatments prioritized under the new Funding Accelerated for Specific Treatments (FAST) program for newly diagnosed chronic myeloid leukemia (search) (CML (search)) patients.
The landmark program makes Ontario the first province in Canada to fast-track public access to breakthrough cancer (search) therapies, significantly reducing wait times for patients in need of new cancer treatments. By leveraging Health Canada's Project Orbis pathway to accelerate regulatory approvals, the FAST program ensures innovative therapies can reach eligible patients nearly a year sooner, addressing critical barriers to timely cancer care.
Revolutionary Treatment Access Initiative
"For thousands of Ontarians facing a cancer (search) diagnosis, fast access to treatment is critical, which is why our government is transforming cancer care and speeding up access to new and life-changing treatment options," said Sylvia Jones, Deputy Premier and Minister of Health. "As one of the first new therapies available through our historic Fast Access to Specific Treatment program, Scemblix will help more patients living with chronic myeloid leukemia (search) get the care they need sooner."
The urgency of this initiative resonates deeply with patient advocates. "People living with cancer (search) don't have time to wait for life-saving treatments," said Lisa Machado, founder of the Canadian CML Network (search). "As someone living with CML (search), I know personally how critical timely access to treatment is. I hope Ontario's FAST program will drive similar initiatives across Canada — patients deserve it."
Novel Therapeutic Mechanism
Scemblix represents a significant advancement in CML (search) treatment, being the first therapy that works by specifically targeting the ABL Myristoyl Pocket (search), referred to as a STAMP inhibitor in scientific literature. This mechanism differs from current approved CML treatments, which are tyrosine kinase inhibitors (TKIs (search)) that target the adenosine triphosphate (ATP)-binding site.
In July 2025, Health Canada granted a Notice of Compliance for Scemblix for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (search) (Ph+ CML (search)) in chronic phase who are newly diagnosed or who have previously received one or more tyrosine kinase inhibitors.
Clinical Impact and Patient Benefits
Dr. Dennis Kim, Professor of Medicine at Princess Margaret Cancer Centre, emphasized the clinical significance of improved access. "For CML (search) patients, timely access to treatment is critical for empowering patients to live their lives more fully," he said. "As care providers, we see how earlier access to personalized therapies can transform the patient journey. The FAST program can help reduce wait times for access, making treatments like Scemblix more accessible to patients."
The inclusion of Scemblix in the FAST program follows its positive recommendation by the Canadian Drug Agency (search) (CDA) for newly diagnosed CML (search) patients. CDA's recommendation for patients previously treated with one TKI is currently under review, while patients previously treated with at least two TKIs (search) have been eligible for public reimbursement since 2023.
Disease Burden and Treatment Landscape
Chronic myeloid leukemia (search) is a type of cancer (search) that develops in the blood-forming cells of the bone marrow. In 95% of patients with CML (search), a genetic mutation produces an abnormal chromosome in bone marrow stem cells known as the Philadelphia chromosome. The Ph chromosome produces the BCR-ABL1 (search) protein, which causes bone marrow to make too many abnormal white blood cells that can overcrowd healthy blood cells, potentially proving fatal if untreated.
According to the most recently available data, 665 Canadians were diagnosed with CML (search) in 2019 and 140 Canadians died from CML in 2022. CML has three stages: chronic, accelerated, and blast phases, with most patients diagnosed in the chronic phase. With proper treatment, patients can often stay in this early stage without advancing further.
Industry Commitment and Future Expansion
"Ontario's leadership in launching the FAST program is a powerful step forward in reimagining how patients access new cancer (search) treatments," said Erin Keith, Vice President of Oncology, Novartis Canada (search). "At Novartis Canada, we are proud to collaborate with government and healthcare partners to bring therapies, like Scemblix, to patients sooner, and we remain committed to working toward expanding this vision across Canada to ensure no patient is left waiting for the care they need."
Novartis Canada (search) has been at the forefront of CML (search) treatment innovation for over two decades, advancing care through groundbreaking therapies that address specific patient challenges. The company employs approximately 500 people in Canada and invests over $30 million in R&D yearly in the country.