Novartis Secures EU Approval for Kisqali® in Early Breast Cancer Treatment

Basel, November 27, 2024 Novartis has received European Commission (EC) approval for Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) as an adjuvant treatment for hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence. This decision is based on the Phase III NATALEE trial, which demonstrated a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone.

The trial, which included patients with stage II and III HR+/HER2-EBC, showed consistent benefits across various patient subgroups, including those with node-negative disease. Experts like Dr. Michael Gnant from the Medical University of Vienna and Dr. Michael Untch from Helios Klinikum Berlin-Buch hailed the approval as a crucial development in reducing breast cancer recurrence risks.

This approval follows Kisqali’s recent FDA nod and its recognition as a preferred adjuvant treatment by NCCN Guidelines®. Novartis remains committed to global regulatory review and further evaluation of long-term outcomes for Kisqali in EBC patients, aiming to address unmet needs and improve survival rates in the early breast cancer community.