Canada Grants Approval for Ribociclib as Adjuvant Therapy in Early Breast Cancer
Health Canada has granted a Notice of Compliance (NOC) to Novartis, allowing the approval of adjuvant ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) for the treatment of adult patients with hormone receptor–positive, HER2-negative, stage II/III early breast cancer at a high risk of recurrence.**
This regulatory decision was supported by data from the pivotal phase 3 NATALEE trial, which showed significant improvements in invasive disease-free survival with the addition of ribociclib to endocrine therapy compared to endocrine therapy alone.
According to the trial's results, patients treated with ribociclib plus endocrine therapy experienced a reduced risk of disease recurrence or death by 25%. The estimated 3-year invasive disease-free survival rate was 90.4% in the ribociclib arm versus 87.1% in the control arm.
Dr. Stephen K.L. Chia, MD, FRCPC, a medical oncologist at BC Cancer, Vancouver Cancer Centre, welcomed the approval, stating that it provides a new and expanded treatment option for patients with early breast cancer. He emphasized the importance of patient-centered care and balancing risk-benefit discussions to ensure the best possible treatment decisions.
Ribociclib remains the only CDK4/6 inhibitor to demonstrate statistically significant overall survival benefits in three separate phase 3 trials in patients with advanced breast cancer, according to Novartis.
Health Canada Approval Paves Way for Expanded Treatment Option
The NATALEE trial demonstrated that ribociclib can reduce the risk of recurrence and improve outcomes, particularly for patients at elevated risk. With over 100,000 patients with metastatic breast cancer treated globally with Kisqali, this approval expands treatment options for stage II/III hormone receptor–positive/HER2-negative early breast cancer.
Mark Vineis, country president of Novartis Canada, stated that the company is committed to expanding timely access to ribociclib and working collaboratively with healthcare system partners to improve health outcomes.