– Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease.

This approval is based on data from the pivotal Phase III NATALEE trial, which demonstrated that Kisqali plus endocrine therapy (ET) significantly reduced the risk of disease recurrence by 25.1% compared to ET alone. The trial showed consistent benefit across all subgroups, including patients with node-negative disease. Kisqali’s established safety profile was maintained in the early-stage setting.

“Today’s approval allows us to offer a broader group of patients a powerful tool to minimize the risk of cancer recurrence,” said Dr. Dennis J. Slamon, lead investigator of the NATALEE trial.

The approval of Kisqali marks a significant step forward in expanding adjuvant treatment options for people with HR+/HER2- EBC and underscores Novartis’ commitment to improving outcomes for breast cancer patients worldwide.