Novartis Announces EU Approval of Kisqali as Adjuvant Therapy for High-Risk Early Breast Cancer

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

This approval is based on the results of the pivotal Phase 3 clinical trial NATALEE, which covered a broad patient population, including those with HR+/HER2- early-stage breast cancer in stages II and III, including patients without lymph node involvement. 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). Improvement in invasive disease-free survival (iDFS) was consistently observed across all patient subgroups.

The latest analysis of the NATALEE trial, recently presented at the 2024 European Society for Medical Oncology (ESMO) Congress, further strengthens the data under FDA review. The results show that patient benefits deepened further after a three-year treatment period, with a 28.5% reduction in recurrence risk among patients receiving the Kisqali combination therapy compared to those treated with ET alone (HR=0.715; 95% CI: 0.609, 0.840; P<0.0001). Novartis will continue to evaluate long-term outcomes for NATALEE patients, including overall survival.