Novartis announces EC approved Kisqali in combination with an inhibitor

Novartis (NVS) announced that the European Commission, EC, has approved Kisqali in combination with an aromatase inhibitor, AI, for the adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2, HER2, -negative early breast cancer, EBC, at high risk of recurrence. The approval is based on results from the pivotal Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III EBC, including those with node-negative disease2. The trial showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy compared to ET alone. The invasive disease-free survival benefit was consistently observed across all patient subgroups. Regulatory review of Kisqali in EBC is ongoing worldwide. Following recent data announcements at ESMO 20246, Novartis will continue to evaluate NATALEE patients for longer-term outcomes, including overall survival.