Novartis gains FDA nod for broader early breast cancer treatment use

The FDA has granted approval for the use of Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor to treat patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) who are at high risk of recurrence. This decision widens the scope of patients who can benefit from CDK4/6 inhibitor therapy, now including those with node-negative disease.

The approval is based on data derived from the Phase III NATALEE trial. In this trial, the combination of Kisqali and endocrine therapy (ET) was found to reduce the risk of cancer recurrence by 25.1% compared to ET alone. This significant decrease in recurrence risk was consistent across all patient subgroups. Further examination of the trial's updated results showed an even more substantial reduction in recurrence risk—28.5%—beyond the three-year treatment period.

Kisqali, which has been previously utilized in the treatment of metastatic breast cancer, is currently undergoing regulatory review for early breast cancer treatment in several regions, including the European Union. This recent approval presents a new therapeutic option for patients at a high risk of their cancer returning.