Scemblix® Receives Priority Access in Ontario Under New FAST Program

• Novartis applauds Ontario's bold leadership in launching the FAST program, which accelerates access to breakthrough therapies like Scemblix^® for patients living with cancer.
• Scemblix^® (asciminib) was recently approved for newly diagnosed and previously treated chronic myeloid leukemia (CML) patients with Philadelphia chromosome-positive in chronic phase, offering a new first-line treatment option for Canadian patients.

MONTREAL, Dec. 10, 2025 /CNW/ - Novartis Canada is pleased to announce that Scemblix^® (asciminib) is one of the first therapies to be prioritized for public reimbursement under Ontario's new Funding Accelerated for Specific Treatments (FAST) program for newly diagnosed chronic myeloid leukemia (CML) patients. This landmark initiative makes Ontario the first province in Canada to fast-track public access to breakthrough cancer therapies, like Scemblix^®, significantly reducing wait times for those in need of new cancer treatments.

"For thousands of Ontarians facing a cancer 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 get the care they need sooner as we continue our work to make advanced treatment options more accessible to those who need it most."

"People living with cancer don't have time to wait for life-saving treatments," said Lisa Machado, founder of the Canadian CML Network. "As someone living with CML, 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."

In July 2025, Health Canada granted a Notice of Compliance for Scemblix^® for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who are newly diagnosed or who have previously received one or more tyrosine kinase inhibitors (TKIs).¹ By leveraging Health Canada's Project Orbis pathway to accelerate regulatory approvals to promising cancer treatments, the FAST program ensures innovative therapies can reach eligible patients nearly a year sooner, addressing critical barriers to timely cancer care.

"For CML patients, timely access to treatment is critical for empowering patients to live their lives more fully," said Dr. Dennis Kim, Professor of Medicine at Princess Margaret Cancer Centre. "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. This is a major step forward in placing patients at the core of cancer care."

The inclusion of Scemblix^® in the FAST program follows its positive recommendation by the Canadian Drug Agency (CDA) for newly diagnosed CML patients. CDA's recommendation for patients previously treated with one TKI is currently under review, while patients previously treated with at least two TKIs have been eligible for public reimbursement since 2023. 

"Ontario's leadership in launching the FAST program is a powerful step forward in reimagining how patients access new cancer treatments," said Erin Keith, Vice President of Oncology, Novartis Canada. "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."

For over two decades, Novartis Canada has been at the forefront of innovation for CML treatment, advancing care through groundbreaking therapies that address the specific challenges faced by patients. With therapies like Scemblix^® that redefine what's possible for CML care, Novartis Canada remains committed to delivering solutions that can help transform lives.

About Chronic Myeloid Leukemia (CML)

Chronic myeloid leukemia (CML) is a type of cancer that develops in the blood-forming cells of the bone marrow. In 95% of patients with CML, a genetic mutation produces an abnormal chromosome in bone marrow stem cells known as the Philadelphia chromosome ("Ph chromosome"). When the Ph chromosome is present, CML is classified as Philadelphia chromosome-positive (Ph+).²

The Ph chromosome produces the BCR-ABL1 protein, which causes bone marrow to make too many abnormal white blood cells. These cells overcrowd healthy blood cells, which can be fatal if untreated.²

CML has three stages: chronic, accelerated, and blast phases. Most patients are diagnosed in the chronic phase, and with proper treatment, can often stay in this early stage without advancing further.²

According to the most recently available data, 665 Canadians were diagnosed with CML in 2019 and 140 Canadians died from CML in 2022.³

About Scemblix^® (asciminib)

Scemblix^® is the first CML treatment that works by specifically targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature).^{4, 5} The current approved CML treatments are TKIs that target the adenosine triphosphate (ATP)-binding site (ATP-competitive).¹

About Novartis

Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious diseases. Our medicines reach more than 250 million people worldwide.

In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 500 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit www.novartis.ca.

SCEMBLIX^® is a registered trademark.

References

SOURCE Novartis Pharmaceuticals Canada Inc.