Unlike rival CDK 4/6 inhibitor abemaciclib, patients don't need to be lymph-node positive to receive ribociclib after surgery.

Kisqali is a selective cyclin-dependent kinase inhibitor that targets proteins involved in the rapid division of cancer cells.

The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.

The drug joins abemaciclib (Verzenio) as approved CDK4/6 inhibitors in this setting, but the broader indication for ribociclib -- which includes node-negative (N0) disease -- roughly doubles the population of early breast cancer patients eligible for adjuvant therapy with a CDK4/6 inhibitor, according to drugmaker Novartis.

The Food and Drug Administration (FDA) has just approved the drug Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) as treatment for people with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence.

Findings from the NATALEE trial show that the combination of Kisqali and an aromatase inhibitor resulted in disease-free benefits in a breast cancer subset.

Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive,

Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday.