Novartis Canada has welcomed a positive draft recommendation from Canada’s Drug Agency (CDA-AMC) supporting the public reimbursement of Kisqali® (ribociclib tablets) for all eligible patients with high-risk early breast cancer (eBC), a move that could significantly expand access to the treatment nationwide.
The draft recommendation, if finalized, would pave the way for Kisqali to be reimbursed for adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) stage II–III early breast cancer who face a high risk of recurrence. Kisqali is prescribed after surgery, in combination with an aromatase inhibitor, to help prevent the cancer from returning.
Patient advocacy groups described the development as a major milestone. Kimberly Carson, CEO of Breast Cancer Canada, said the recommendation represents “a significant and welcome step forward” for patients, noting that it brings Canada closer to ensuring timely and equitable access to evidence-based therapies. She added that recognizing the persistent fear and risk of recurrence faced by patients is essential to improving long-term outcomes.
Health Canada approved Kisqali for this early breast cancer indication in June 2025. Clinical trial data showed the drug reduced the risk of recurrence by 28% across a broad population of high-risk eBC patients. Notably, among patients with high-risk features but no lymph node involvement, Kisqali achieved a 40% reduction in recurrence risk at five years of follow-up.
Clinicians also welcomed the draft decision. Dr. Katarzyna Jerzak, a medical oncologist at Sunnybrook’s Odette Cancer Centre and associate professor at the University of Toronto, said the recommendation meaningfully advances treatment options for early-stage HR+/HER2- breast cancer. She noted that broader access allows physicians to better personalize treatment and proactively address recurrence risk.
In its draft assessment, CDA-AMC cited the significant unmet need for additional therapies in early breast cancer and highlighted the statistically meaningful benefit Kisqali demonstrated in reducing recurrence risk across all eligible patient groups.
Dimitri Gitas, Country President of Novartis Canada, said the recommendation reflects a shared commitment to ensuring innovative therapies reach patients who can benefit from them. “By advancing the treatment landscape in early breast cancer, we are working toward a future where more people can manage their health with greater confidence,” he said.
Once CDA-AMC issues its final recommendation, the submission will move to the pan-Canadian Pharmaceutical Alliance (pCPA) for pricing and reimbursement negotiations. Novartis emphasized that swift action by provincial and territorial governments will be critical to avoid delays in patient access.
Breast cancer remains the most commonly diagnosed cancer among Canadian women, with roughly 70% of cases identified at an early stage. Despite current therapies, patients with stage II and III HR+/HER2- disease continue to face a substantial risk of recurrence. Research indicates that nearly a quarter of patients without lymph node involvement may experience recurrence within 20 years, and most metastatic breast cancer cases originate from earlier-stage disease.
Kisqali, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, was first approved in Canada in 2018 for advanced or metastatic HR+/HER2- breast cancer. In the early breast cancer setting, it is the only CDK4/6 inhibitor recommended for all node-positive patients as well as those with high-risk disease characteristics without nodal involvement. The drug is also endorsed by major international guidelines, including the National Comprehensive Cancer Network, and has received high clinical benefit ratings from the European Society for Medical Oncology.
Novartis, a global innovative medicines company, said it continues to invest heavily in research and development in Canada while working with health authorities to expand patient access to breakthrough treatments.
