Early breast cancer European approval with CDK4/6 inhibitor adjuvant treatment and oncology regulatory milestone
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Novartis Receives European Commission Approval for Kisqali in Early Breast Cancer

Novartis announces European Commission approval of Kisqali (ribociclib) plus endocrine therapy for HR-positive HER2-negative early breast cancer in the EU.

Novartis today announced that the European Commission has approved Kisqali (ribociclib) in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence in the European Union. The approval was based on results from the Phase 3 NATALEE trial, which demonstrated a statistically significant improvement in invasive disease-free survival. This approval makes Kisqali available as an adjuvant treatment option for early breast cancer patients across all EU member states.

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