Policy & Regulation
Novartis' Kisqali approved in EU for broader population of high-risk early breast cancer patients
27 November 2024 -

Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) announced on Wednesday that the European Commission has approved Kisqali (ribociclib) for the adjuvant treatment of a broader population of patients with HR+/HER2- early breast cancer (EBC) at high risk of recurrence.

The approval is based on data from the Phase III NATALEE trial, which demonstrated a significant reduction in the risk of disease recurrence with Kisqali plus endocrine therapy compared to endocrine therapy alone. This benefit was observed across various patient subgroups, including those with node-negative disease.

This broader approval means that nearly twice as many EBC patients in Europe could now be eligible for treatment with Kisqali, helping to reduce their risk of recurrence.

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