FDA Approves Kisqali / Ribociclib for Early High-Risk Breast Cancer ESMO 2024

Download Slides: https://oncologytube.com/slides-fda-a...

The FDA has approved Kisqali (ribociclib) in combination with a non-steroidal aromatase inhibitor (NSAI) for the treatment of early-stage HR+/HER2- breast cancer in patients at high risk of recurrence. This approval provides a new and powerful treatment option aimed at reducing the risk of cancer recurrence during the critical early stages of the disease.

The approval is based on findings from the NATALEE trial, a phase 3 study involving 5,101 adults with HR-positive, HER2-negative early breast cancer. Patients were randomized to receive ribociclib with NSAI or NSAI alone. Results showed a significant improvement in invasive disease-free survival (iDFS) in patients receiving ribociclib, with a 90.7% iDFS rate at 36 months compared to 87.6% in the NSAI-alone group. This translates to a 25% reduction in the risk of invasive disease or death in patients treated with ribociclib.

The safety profile of Kisqali in the NATALEE trial was consistent with previous findings in metastatic settings, with common side effects including neutropenia, elevated liver enzymes, and fatigue. Regular monitoring of blood counts and liver function is required for patients undergoing treatment.

This breakthrough approval offers a new standard of care for preventing recurrence in high-risk patients with early-stage breast cancer, backed by robust clinical data from the NATALEE trial.