Health Canada has approved Novartis’ KISQALI (ribociclib tablets) in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive (HR+), HER2-negative (HER2-) stage II or III early breast cancer (eBC) at high risk of recurrence. This decision marks a significant advancement in breast cancer treatment, particularly for patients with a higher likelihood of disease return.
HR+/HER2- is the most common subtype of breast cancer, representing about 70% of cases. More than 40% of these are diagnosed at stage II or III, where the risk of recurrence—often metastatic and incurable—can persist for up to two decades. Breast cancer remains a major health concern in Canada, claiming an average of 15 women’s lives daily.
“This Health Canada approval is an exciting step forward,” said MJ DeCoteau, Founder and Executive Director of Rethink Breast Cancer. “Younger patients especially face aggressive forms of HR+ breast cancer with higher recurrence rates. Our community has long awaited more effective treatment options like KISQALI.”
The approval is based on results from the global Phase III NATALEE trial, which showed that ribociclib combined with an aromatase inhibitor significantly reduced the risk of recurrence. Specifically, patients experienced a 25.1% relative reduction in invasive disease-free survival (iDFS) events compared to AI therapy alone, with a favorable safety profile.
Dr. Stephen Chia, a medical oncologist at BC Cancer and NATALEE trial steering committee member, emphasized the importance of the expanded treatment option. “This approval gives patients a new opportunity to reduce the risk of their cancer returning. It’s crucial that treatment decisions are tailored through shared, informed discussions between patients and their healthcare teams.”
Dr. Katarzyna Jerzak of Sunnybrook Health Sciences Centre echoed the significance of the approval, noting that over half of recurrences happen after the initial five years post-diagnosis. “Ribociclib offers a much-needed option for those at higher risk, helping to improve long-term outcomes.”
Mark Vineis, Country President of Novartis Canada, reaffirmed the company’s commitment to breast cancer care. “With over 100,000 patients globally treated with KISQALI for metastatic disease, we are proud to expand its reach to those facing early breast cancer. Our goal is to ensure timely access and support for Canadian patients and providers alike.”
This approval represents a meaningful step in improving the long-term care and survival of Canadians diagnosed with high-risk early breast cancer.