FDA Approves Kisqali for Early-Stage Breast Cancer
On Sept. 17, the U.S. Food and Drug Administration (FDA) approved Kisqali (chemical name: ribociclib) in combination with an aromatase inhibitor after surgery to reduce the risk of recurrence of stage II or stage III hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence. Kisqali had previously been used only to treat advanced-stage and metastatic breast cancers.
The FDA approval was based on results from the NATALEE trial. Findings presented at the 2023 ASCO Annual Meeting showed that after about two years of follow-up, 91% of people with early-stage breast cancer who took Kisqali plus an aromatase inhibitor after breast cancer surgery had no recurrence, compared to about 88% of people who took an aromatase inhibitor alone.
Updated NATALEE results presented at the ESMO 2024 Congress showed that after about four years of follow-up, 91% of people who took Kisqali plus an aromatase inhibitor had no recurrence, compared to 88% of people who took only an aromatase inhibitor.
Listen to NATALEE lead researcher Dennis Slamon, MD, PhD, discuss the results of the study on The Breastcancer.org Podcast.
— Last updated on January 13, 2025 at 2:41 PM