- Novartis’ Kisqali (ribociclib) significantly reduces the risk of breast cancer recurrence by 28.5% in patients with early HR+/HER2- breast cancer, including node-negative cases, as shown in the Phase III NATALEE trial.
- The benefits continue post-treatment, with consistent results across secondary endpoints and manageable safety profiles.
- Regulatory reviews are underway, with FDA action expected in Q3 2024.
Mon Sep 16 07:15:52 -0000 2024 UTC– Novartis’ Kisqali in a new analysis showed a 28.5% reduction in the risk of breast cancer recurrence in patients with early breast cancer. The benefit continued after the three-year treatment, consistent across all patient subgroups.
Safety profile remains good, with low-grade adverse events.
Results will be presented at ESMO, with FDA action expected in Q3. Kisqali added to endocrine therapy proved beneficial in reducing recurrence risk. The trial included a broad population, emphasizing the importance of reducing recurrence risk in early breast cancer patients.