Novartis Canada applauds Canada's Drug Agency (CDA-AMC) for its positive draft recommendation to reimburse Kisqali®? (ribociclib tablets) for all eligible early breast cancer (eBC) patients at high risk of recurrence. Approved by Health Canada in June 2025, Kisqali®?
(ribociclib tablets), in combination with an aromatase inhibitor, is indicated for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III early breast cancer (eBC). In clinical trials, Kisqali®? demonstrated a significant 28% reduction in the risk of recurrence across a broad population of high risk eBC patients.
Within this broad population, a 40% reduction in the risk of Recurrence was achieved for patients who presented with high risk features despite the absence of cancer in their lymph nodes at 5 years follow up. In granting its positive draft recommendation, CDA-AMC acknowledged the significant unmet need for additional treatment options in early breast cancer and highlighted the statistical benefit demonstrated with Kisqali®? in reducing the risk of recurrence across all eligible patients.
Targeting CDK4/6 with enhanced precision aides the control of cancer cell replication. In eBC, Kisqali®? is the only CDK4/6 inhibitor recommended for all node-positive disease as well as patients with high risk disease characteristics despite no nodal involvement.
The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (Kisqali®?) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients.18 Kisqali®? in combination with an aromatases inhibitor (AI), has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of rec recurrence.
