According to the Zhito Finance APP, Novartis (NVS.US) announced today that the European Commission (EC) has approved the CDK4/6 inhibitor Kisqali (ribociclib) in combination with aromatase inhibitors (AI) as adjuvant therapy for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer (EBC) at high risk of recurrence.

This approval is based on the results of the pivotal Phase 3 clinical trial NATALEE, which included a broad patient population, including patients with HR+/HER2- stage II and III early breast cancer, some of whom had no lymph node metastasis. The trial results showed that, compared to endocrine therapy (ET) alone, Kisqali combined with endocrine therapy significantly and clinically meaningfully reduced the risk of disease recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006). 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) conference further solidified the data for FDA review. The results indicated that after three years of treatment, patient benefits deepened, with a 28.5% reduction in the risk of recurrence for patients in the Kisqali combination therapy group compared to those receiving ET alone (HR=0.715; 95% CI: 0.609, 0.840; P<0.0001). Novartis will continue to assess long-term outcomes for NATALEE patients, including overall survival.