Novartis' (NVS.US) key small molecule drug gets EU Commission approval, poised to transform early breast cancer treatment
1min read Novartis (NVS.US) today announced that the European Commission (EC) has approved Kisqali (ribociclib), a CDK4/6 inhibitor, in combination with an aromatase inhibitor (AI), as an adjuvant therapy for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, high-risk early breast cancer (EBC) patients.
This approval is based on the results of the pivotal Phase 3 NATALEE trial, which covered a broad patient population, including HR+/HER2- early breast cancer patients in stages II and III, including those without lymph node metastasis. The trial showed that the combination of Kisqali with endocrine therapy (ET) significantly and clinically reduced the risk of disease recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) compared to ET alone. Improvements in invasive disease-free survival (iDFS) were consistently observed across all patient subgroups.
The latest analysis of the NATALEE trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress, further solidified the data reviewed by the FDA. The results showed that the benefit of the Kisqali combination therapy deepened three years after treatment, with a 28.5% reduction in the risk of recurrence compared to patients receiving ET alone (HR=0.715; 95% CI: 0.609, 0.840; P<0.0001). Novartis will continue to evaluate the long-term results of the NATALEE patients, including overall survival.