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# Kisqali Expanded Approval for Early Breast Cancer
- URL: https://www.fdaweb.com/kisqali-expanded-approval-for-early-breast-cancer/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157795

FDA has approved Novartis’ Kisqali (ribociclib) for combination use with an aromatase inhibitor for the adjuvant treatment of people 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, including those with node-negative (N0) disease.

Approval was based on data from the Phase 3 NATALEE trial, which showed a “significant and clinically meaningful 25.1% (HR=0.749; 95% CI: 0.628, 0.892; *P*\=0.0006) reduction in risk of disease recurrence in a broad population of patients with HR+/HER2- Stage II and III EBC treated with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone, including those with high-risk N0 disease,” the company says. “With this approval, we are redefining treatment options for a broader population of people impacted by breast cancer and facing the persistent risk of recurrence.”

Kisqali is described as a selective cyclin-dependent kinase inhibitor that works by slowing cancer progression through its inhibition of proteins cyclin-dependent kinase 4 and 6 (CDK4/6). “These proteins, when over-activated, can enable cancer cells to grow and divide too quickly,” Novartis says. “Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.”

Previously, Kisqali was approved by FDA for treating metastatic breast cancer.