Health Canada approves Novartis' Kisqali for HR positive, HER2 negative early breast cancer patients at high risk of recurrence

Novartis

18 June 2025 - Health Canada approval is based on the pivotal Phase 3 NATALEE trial data, which demonstrated a clinically meaningful invasive disease-free survival benefit for Kisqali plus adjuvant aromatase inhibitor in patients with stage II or III HR positive, HER2 negative early breast cancer.

Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance for Kisqali (ribociclib tablets) in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative stage II-III early breast cancer at high risk of recurrence.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Canada