Ribociclib indication expanded to include early breast cancer

FDA approved ribociclib (Kisqali) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The ribociclib and letrozole co-pack (Kisqali Femara Co-Pack) was also approved for the same indication. Approval was based on data from the phase 3 NATALEE trial. According to a manufacturer press release, the broader indication approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy.