Health Canada approves Novartis’ Kisqali for high-risk early breast cancer

CANADA— Health Canada has approved Novartis Canada’s Kisqali (ribociclib tablets) in combination with an aromatase inhibitor for the adjuvant treatment of adults with stage II-III early breast cancer (eBC) who are at high risk of recurrence.

This approval is based on the results of the global Phase III NATALEE trial, which demonstrated a significant reduction in the risk of invasive disease recurrence when ribociclib was added to standard hormone therapy compared to hormone therapy alone.

The NATALEE study enrolled over 5,100 patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer from 20 countries.

The trial showed a 25.1% relative reduction in invasive disease-free survival (iDFS) events with the combination treatment, highlighting its effectiveness in preventing cancer recurrence in this high-risk population.

The 3-year iDFS rate was 90.4% for patients receiving ribociclib plus an aromatase inhibitor, compared to 87.1% for those on aromatase inhibitor alone.

Kisqali works by selectively inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), proteins that are often overactive in cancer cells and drive their rapid growth and division. By targeting these kinases, Kisqali slows down tumor progression.

It is currently the only CDK4/6 inhibitor recommended for patients with node-positive early breast cancer as well as those without nodal involvement but with other high-risk disease features.

Novartis Canada’s country president, Mark Vineis, emphasized the company’s long-standing commitment to breast cancer research, noting that over 100,000 people worldwide with HR+/HER2- metastatic breast cancer have been treated with Kisqali.

The new approval expands its use to earlier stages of the disease, aiming to reduce the risk of recurrence and improve long-term outcomes for patients.

Vineis also highlighted Novartis’s dedication to working with healthcare partners to ensure timely access to Kisqali and support for patients and clinicians across Canada.

This approval marks an important advancement in breast cancer treatment, providing a new option beyond hormone therapy alone for patients with early-stage HR+/HER2- breast cancer at elevated risk of recurrence.

 Since its initial approval by Health Canada in March 2018 for advanced or metastatic breast cancer, Kisqali has established itself as a key therapy in this area.

The current decision reinforces its role in personalized cancer care, offering hope to thousands of Canadians facing early breast cancer.

In February 2025, Novartis Canada received approval for Fabhalta (iptacopan capsules), the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH) and hemolytic anemia, further expanding its portfolio of innovative treatments alongside Kisqali.

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