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European Medicines Agency's CHMP recommends Novartis' Kisqali for high-risk early breast cancer adjuvant treatment based on NATALEE trial data.
Novartis' breast cancer drug Kisqali (ribociclib) has received a favorable opinion from the European Medicines Agency's CHMP for use as an adjuvant treatment in adults with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence.
This recommendation is based on Phase III NATALEE trial data, indicating a 25% reduction in recurrence risk.
The European Commission's final decision is expected in about two months.
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El CHMP de la Agencia Europea de Medicamentos recomienda Kisqali de Novartis para el tratamiento adyuvante temprano del cáncer de mama de alto riesgo basado en los datos del ensayo NATALEE.