Novartis’ Kisqali Secures Broad FDA Approval for Adjuvant Treatment of Early Breast Cancer

FDA Approval:
The FDA has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease.

Clinical Benefits:
Kisqali significantly reduced the risk of recurrence by 25% compared to endocrine therapy alone in the pivotal Phase III NATALEE trial, demonstrating a consistent benefit and well-tolerated safety profile across all subgroups, including patients with node-negative disease.

Broad Indication:
This approval approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy, addressing a significant risk of recurrence in people with stage II or III HR+/HER2- early breast cancer.

Long-term Efficacy:
Recent data presented at ESMO showed a deepening of invasive disease-free survival benefit after completion of the three-year treatment period across all patient subgroups, providing additional confidence in Kisqali's efficacy.

Regulatory Review:
Kisqali is under regulatory review worldwide, including in the EU, for the early breast cancer indication, further expanding its potential reach.

Established Treatment:
Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials in metastatic breast cancer, solidifying its position as a preferred treatment option.