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[HEALTH] · United States, EU · 2 sources

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Novartis Kisqali reduces early breast cancer mortality by 19%

Novartis has released long-term data from its Phase III Natalee study, demonstrating that Kisqali (ribociclib) combined with hormone therapy reduces the risk of death by approximately 19% in patients with early-stage, HR-positive, HER2-negative breast cancer.

The study, which involved approximately 5,100 patients across 20 countries, observed participants over a six-year period. The data indicates that the survival benefit increased over time, with the difference in overall survival between the Kisqali group and the hormone therapy-only group rising from 1.2% at five years to 2.1% at six years. The benefit also extended to recurrence-free survival endpoints.

Kisqali is already approved in over 100 countries, including the United States and the European Union, for both early-stage high-risk breast cancer and advanced or metastatic cases. The safety profile remained stable throughout the study period with no new side effects reported.

Entities

European Society for Medical Oncology · Novartis