Novartis (NVS) has announced that the European Commission has granted approval for the use of Kisqali (ribociclib) in combination with an aromatase inhibitor as an adjuvant treatment for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer who are at high risk of recurrence.
This decision is supported by findings from the pivotal Phase III NATALEE trial, which encompassed a diverse group of patients with HR+/HER2- stage II and III early breast cancer, including those without node involvement.
The trial results demonstrated a significant 25.1% reduction in the risk of disease recurrence for patients treated with adjuvant Kisqali alongside endocrine therapy, as opposed to endocrine therapy alone. The improvement in invasive disease-free survival was consistent across all patient demographics.
This approval by the European Commission follows the recent authorization by the U.S. Food and Drug Administration (FDA) for Kisqali as a treatment for early-stage breast cancer and its recommendation as a Category 1 preferred adjuvant treatment in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.
Novartis has indicated that regulatory reviews for Kisqali's use in early breast cancer are ongoing globally.
