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European Commission Approves Kisqali® for HR+/HER2- Early Breast Cancer at High Risk of Recurrence

NextEdge Admin

28 Nov 2024

2 min 51 sec

European Commission,breast cancer,Approval

Novartis announced that the European Commission (EC) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence.

This decision is supported by data from the Phase III NATALEE trial, which included a diverse population of HR+/HER2- stage II and III EBC patients, including those with node-negative disease. The trial demonstrated a significant 25.1% reduction in the risk of disease recurrence with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone (HR=0.749; 95% CI: 0.628–0.892; P=0.0006). The invasive disease-free survival (iDFS) benefit was consistent across all patient subgroups, underscoring Kisqali's broad efficacy.

“For patients with stage II or III HR+/HER2- early breast cancer, the risk of recurrence remains significant even after years,” said Michael Gnant, M.D., from the Medical University of Vienna. He noted this approval as a "positive milestone" offering hope to patients and physicians. Michael Untch, M.D., from Helios Klinikum Berlin-Buch, highlighted Kisqali's potential to benefit patients with node-negative disease and additional risk factors.

Breast cancer remains Europe’s most common cancer diagnosis, with 70% of cases detected in early stages. However, stage II and III HR+/HER2- EBC patients remain at risk of long-term recurrence, often resulting in incurable advanced disease.

Iris Zemzoum, M.D., President of Novartis Europe, emphasized Kisqali’s role in addressing this unmet need and improving outcomes for a broader patient population. This EC approval follows the U.S. FDA’s recent approval and Kisqali’s inclusion as a Category 1 preferred adjuvant therapy in NCCN Guidelines®.

Ongoing global regulatory reviews and long-term survival assessments for Kisqali will further solidify its role in EBC care.