FDA approved ribociclib combinations for early high-risk breast cancer in 2024

The FDA approved ribociclib, marketed as Kisqali by Novartis Pharmaceuticals Corporation, in combination with an aromatase inhibitor, along with a ribociclib and letrozole co-pack marketed as Kisqali Femara Co-Pack, also from Novartis Pharmaceuticals Corporation, for early high-risk breast cancer. The approval was granted on September 17, 2024.¹

The FDA record provided does not include further details on the trial data, dosing specifics, or efficacy endpoints that supported this approval. Readers seeking those specifics should consult the full prescribing information or the underlying clinical trial registry entries, which are not part of this document.