Health Canada has granted approval for the use of ribociclib (marketed as Kisqali) in combination with an aromatase inhibitor as adjuvant therapy for adults with hormone receptor–positive, HER2-negative early breast cancer (stage II or III) at high risk of recurrence. This decision expands treatment options beyond endocrine therapy alone and marks a key milestone in supporting patients prone to aggressive disease.
The approval is supported by results from the global Phase III NATALEE trial involving over 5,100 patients. Participants receiving ribociclib plus an aromatase inhibitor demonstrated a 25% reduction in the risk of invasive disease recurrence or death compared to those on endocrine therapy alone. At a median follow-up of around 28 months, the 3‑year invasive disease‑free survival (iDFS) rate was 90.4% in the ribociclib group versus 87.1% in the control group, indicating a meaningful improvement in patient outcomes.
Ribociclib belongs to the CDK4/6 inhibitor class, which slows cancer cell proliferation by targeting key enzymes in the cell cycle. This targeted approach makes it a powerful addition when combined with hormonal therapy, particularly for patients facing a high likelihood of relapse. Health Canada’s label specifies its use in patients with stage II or III disease, including both node‑positive and node‑negative disease when other high‑risk features are present.
Safety data from the NATALEE study revealed expected side effects consistent with prior findings. Neutropenia was the most common adverse event, affecting more than 60% of patients, followed by infections, nausea, fatigue, and liver enzyme elevations. Most adverse effects were manageable through dose adjustments and supportive care, and treatment discontinuation rates remained low overall.
Experts across Canada and abroad have welcomed the approval. Medical oncologists highlighted that this offers a new tool to reduce recurrence risk in a large subset of early breast cancer patients—especially given that up to one-third of high-risk cases can relapse even after standard therapy. Clinical guidelines, such as those from NCCN and ESMO, have increasingly recognized ribociclib’s role based on its clinical benefit and safety record.
This regulatory decision places Canada alongside the U.S. and European Union, both of which approved ribociclib in the adjuvant setting in late 2024. Notably, ribociclib remains the only CDK4/6 inhibitor to demonstrate an overall survival benefit in advanced disease, reinforcing confidence in its extended use.
Novartis Canada, led by Country President Mark Vineis, noted that ribociclib has already treated over 100,000 patients worldwide with metastatic breast cancer. The expansion into early-stage disease aligns with the company’s mission to reduce recurrence and improve long-term outcomes in this patient population.
Access to ribociclib in Canada is now available, and clinicians are expected to integrate it into treatment plans for patients meeting the criteria. As physicians begin prescribing, ongoing education and monitoring protocols will support safe and appropriate use.
In summary, Health Canada’s approval of ribociclib plus endocrine therapy for high-risk, early HR+/HER2– breast cancer marks a major advance in adjuvant treatment. It combines targeted therapy with hormonal treatment to significantly reduce recurrence risk, backed by robust trial data. This approval delivers hope for thousands of Canadians facing an uncertain diagnosis and represents a new standard of care grounded in evidence-led innovation.