FDA Approves Novartis' Kisqali (Ribociclib) for Early Breast Cancer

Sep 17, 2024, 08:50 PM

The FDA has approved Novartis' drug Kisqali (ribociclib) for the treatment of adults with stage 2 and 3 hormone receptor-positive, HER2-negative breast cancer at high risk of recurrence. This expanded approval, based on the efficacy and safety results of the NATALEE trial, will allow tens of thousands of women access to a drug that could help prevent their cancer from returning. The approval also includes the use of ribociclib in combination with an aromatase inhibitor. This development is expected to significantly expand the market for Kisqali, giving it a competitive edge over rival treatments.