Novartis wins FDA approval for expanded use of early breast cancer therapy

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.