The FDA has approved Novartis' Kisqali (ribociclib) for use with an aromatase inhibitor in treating individuals 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.
This approval expands the population eligible for CDK4/6 inhibitor therapy, including those with node-negative disease.
The approval is supported by data from the Phase III NATALEE trial, which showed a 25.1% reduction in recurrence risk for patients treated with Kisqali plus endocrine therapy (ET) compared to ET alone. The benefit was observed across all patient subgroups, with updated results indicating a 28.5% reduction in recurrence risk beyond the three-year treatment period.
Kisqali, already used in metastatic breast cancer, is now under regulatory review for early breast cancer treatment in multiple regions, including the EU. The approval offers a new option for those facing a significant risk of recurrence.
