Health Canada has granted a notice of compliance for Novartis Canada’s Kisqali (ribociclib tablets) plus an aromatase inhibitor for the adjuvant treatment of adults with stage II-III early breast cancer (eBC) at elevated recurrence risk.
The approval, supported by the randomised Phase III NATALEE study, is for individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) eBC.
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The global trial comprised subjects with stage II and III eBC disease. It revealed a decrease in the invasive disease-free survival event risk for the combo, against the aromatase inhibitor alone.
Kisqali, which functions as a selective cyclin-dependent kinase inhibitor, targets proteins cyclin-dependent kinase 4 and 6 (CDK4/6) that are often over-activated in cancer cells, leading to rapid growth and division.
In treating eBC, the tablets are the only CDK4/6 inhibitor recommended for node-positive disease as well as for those without nodal involvement but with high-risk characteristics of the disease.
Novartis Canada country president Mark Vineis stated: “Novartis has been advancing innovative research and medical practice in breast cancer care for over 35 years, developing one of the most comprehensive pipelines in the field.
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By GlobalData“Over 100,000 people with HR+/HER2- metastatic breast cancer have been treated with KISQALI globally, and now we’re focused on expanding its use to those with stage II or III HR+/HER2- early breast cancer to reduce risk of recurrence.
“We are actively committed to working with our health system partners to ensure timely access to Kisqali and supporting Canadians and healthcare professionals to improve health outcomes.”
In March 2018, Health Canada approved the therapy to treat individuals with HR+/HER2- advanced or metastatic breast cancer.
In February 2025, Health Canada approved Novartis Canada’s Fabhalta (iptacopan capsules) as the first oral monotherapy to treat the adult population with paroxysmal nocturnal haemoglobinuria (PNH) and haemolytic anaemia.
