Sept. 20, 2024—Novartis announced FDA approval of Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of people with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease.
The approval is based on results from the pivotal phase three NATALEE trial, which showed a significant and clinically meaningful 25.1 percent (hazard ratio, 0.749; 95 percent confidence interval, 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 early breast cancer treated with adjuvant Kisqali plus endocrine therapy compared with endocrine therapy alone. The invasive disease-free survival benefit was consistently observed across all patient subgroups.
“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,” Victor Bultó, president, U.S., Novartis, said in a press release. “We continue to transform cancer care with Kisqali, building on its established profile in the metastatic setting and now helping a wide range of people as they strive to stay cancer free following an early-stage diagnosis.”
Regulatory reviews for Kisqali as an early breast cancer treatment are ongoing worldwide, including in the European Union and China.